WO2014055936A1

WO2014055936A1 - Preservation of biological materials in non-aqueous fluid media

Info

Publication number: WO2014055936A1
Application number: PCT/US2013/063558
Authority: WO
Inventors: Michael Hogan
Original assignee: Integenx Inc.
Priority date: 2012-10-04
Filing date: 2013-10-04
Publication date: 2014-04-10

Abstract

The disclosure provides compositions comprising a biological material (e.g., a protein, a nucleic acid or a biological sample, or any combination thereof) in a substantially water-free, non-ionic or ionic organic solvent. To enhance, e.g., the stability and/or the solubility of the biological material in the substantially water-free fluid medium, the composition can comprise one or more substances (e.g., an antioxidant) described in the disclosure, and/or a metal salt. The biological material is soluble and stable, and retains its function and activity, when it is preserved in the substantially water- free fluid medium at ambient temperature or higher for extended periods of time. Therefore, the composition comprising the biological material does not need to be refrigerated or frozen during shipping or storage.

Description

Preservation of Biological Materials in Non-Aqueous Fluid Media

Reference to Other Applications

[0001] This application claims the benefit of the filing dates of USSN 61/709,417, filed October 4, 2012, USSN 61/786,171, filed March 14, 2013, and USSN 61/885,433 filed

October 1, 2013, all of which are incorporated by reference in their entirety.

Statement as to Federally Sponsored Research

[0002] This invention was made with government support under Contract No. HR0011-12-C- 0005 awarded by the Defense Advanced Research Projects Agency (DARPA). The government has certain rights in the invention.

Background of the Disclosure

[0003] Biological materials, such as proteins and nucleic acids, may in certain instances, be freeze-dried (lyophilized) to enhance their stability in the absence of refrigeration. Freeze-drying comprises freezing of an aqueous mixture containing a biological material and removal of water via sublimation. Biological materials can suffer denaturation (e.g., partial denaturation) as a result of freeze-drying, e.g., as a result of the freezing step and/or the sublimation step.

Summary of the Disclosure

[0004] The present disclosure provides for preservation of biological materials, such as proteins, nucleic acids and biological samples, in substantially water-free fluid media. In a certain

embodiments the water free fluid media has boiling point higher than than of water. The biological materials are soluble and stable in the substantially water- free fluid media at ambient temperature or higher for extended periods of time, and thus do not need to be refrigerated or frozen during shipping or storage. The biological materials retain their structural integrity, function and activity after preservation in the substantially water- free fluid media at ambient temperature or higher for extended periods of time. Because the biological materials are preserved in a fluid medium, they may not need to be re-dissolved for use in fluid-phase reactions or assays, including nucleic acid amplification reactions based on polymerase chain reaction (PCR) and analytical and diagnostic assays, such as immunoassays.

[0005] The disclosure provides compositions comprising a biological material in a substantially water-free fluid medium, wherein the fluid medium comprises a non-ionic organic solvent (e.g., an alcohol solvent) or an ionic organic solvent comprising an organic salt and an organic hydrogen bond donor. To enhance, e.g., the stability and/or the solubility of the biological material in the substantially water-free fluid medium, the compositions can further comprise a metal salt, and/or one or more substances selected from the group consisting of reducing agents, antioxidants, free radical scavengers, oxygen radical scavengers, hydroxyl radical scavengers, singlet oxygen quenchers, hydroperoxide -removing agents, protease inhibitors, nuclease inhibitors, ribonuclease (RNase) inhibitors, deoxyribonuclease (DNase) inhibitors, metal chelators, preservatives, anti-microbials, buffers (or buffering agents), detergents, and chaotropes.

[0006] The disclosure further provides methods of preserving a biological material, comprising mixing an aqueous mixture comprising a biological material with a non-ionic organic solvent (e.g., an alcohol solvent) or an ionic organic solvent comprising an organic salt and an organic hydrogen bond donor to produce an aqueous organic mixture, and removing water from the aqueous organic mixture, e.g., by evaporation, to produce a substantially water-free fluid medium comprising the biological material and the non-ionic or ionic organic solvent. The fluid medium can further comprise a metal salt and/or one or more substances as described herein.

[0007] In addition, the disclosure provides containers and kits containing compositions that comprise biological materials in substantially water- free fluid media.

Brief Description of the Drawings

[0008] A better understanding of features and advantages of the present disclosure will be obtained by reference to the following detailed description, which sets forth illustrative embodiments of the disclosure, and the accompanying drawings.

[0009] Figure 1 shows electrophoresis results of reverse transcription PCR (RT-PCR) for analysis of human 18S ribosomal RNA (rRNA) after preservation of RT-PCR reagents in glycerol, with addition of no sucrose or varying amounts of sucrose, at ambient temperature for varying periods of time.

[0010] Figures 2 and 3 show electropherograms of multiplex PCR for analysis of all 13 short tandem repeat (STR) loci utilized in the CODIS forensic database, as well as Penta D, Penta E and amelogenin, after preservation of PCR reagents in glycerol, with addition of no sucrose or varying amounts of sucrose, at ambient temperature for varying periods of time.

[0011] Figure 4 shows mixtures containing human serum solids and varying amounts of glycerol and sucrose after removal of water under reduced pressure.

[0012] Figures 5 A and 5B show electrophoresis results when RT-PCR for analysis of human 18S rRNA was performed at time = 0 or about 7 days after sucrose and glycerol or 1,3 -propanediol, and optionally mineral oil or a detergent, had been added to a master mix of RT-PCR reagents.

[0013] Figure 6a-c shows the effect of dry storage of IgA, IgGl and IgM at 25°C in several high boiling point alcohol solvents for (a) 5 hrs room temperature, (b) 3 hrs room temperature and 2 hrs at 37 °C, and (c) 3 hrs room temperature and 2 hrs at 56 °C. [0014] Figure 7 shows quantitative recovery of serum immunoglobulin activity in all three of IgA, IgGl, IgM relative to the matched untreated serum sample (green arrow).

[0015] Figure 8 shows preservation of PCR reagents in glycerol plus sucrose or sorbitol for STR-based human identification.

Detailed Description of the Disclosure

[0016] While various embodiments of the present disclosure are described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only.

Numerous modifications and changes to, and variations and substitutions of, the embodiments described herein will be apparent to those skilled in the art without departing from the disclosure. It is understood that various alternatives to the embodiments described herein may be employed in practicing the disclosure. It is further understood that every embodiment of the disclosure may optionally be combined with any one or more of the other embodiments described herein which are consistent with that embodiment.

[0017] Headings are included herein for reference and to aid in locating certain sections.

Headings are not intended to limit the scope of the embodiments and concepts described in the sections under those headings, and those embodiments and concepts may have applicability in other sections throughout the entire disclosure.

[0018] All patent literature and all non-patent literature cited herein are incorporated herein by reference in their entirety to the same extent as if each patent literature or non-patent literature were specifically and individually indicated to be incorporated herein by reference in its entirety.

[0019] The term "exemplary" as used herein means "serving as an example, instance, or illustration". Any embodiment characterized herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.

[0020] Whenever the term "about" or "approximately" precedes the first numerical value in a series of two or more numerical values or in a series of two or more ranges of numerical values, the term "about" or "approximately" applies to each one of the numerical values in that series of numerical values or in that series of ranges of numerical values. In certain embodiments, the term "about" or "approximately" means within 10% or 5% of the specified value.

[0021] Whenever the term "at least" or "greater than" precedes the first numerical value in a series of two or more numerical values, the term "at least" or "greater than" applies to each one of the numerical values in that series of numerical values. [0022] Whenever the term "no more than" or "less than" precedes the first numerical value in a series of two or more numerical values, the term "no more than" or "less than" applies to each one of the numerical values in that series of numerical values.

[0023] In some embodiments, the term "ambient temperature" or "room temperature" refers to a temperature range from about 18 °C to about 27 °C, or from about 20 °C to about 25 °C, or from about 22 °C to about 25 °C. In other embodiments, the term "ambient temperature" or "room temperature" refers to a temperature of about 18 °C, 19 °C, 20 °C, 21 °C, 22 °C, 23 °C, 24 °C, 25 °C, 26 °C or 27 °C. In certain embodiments, the term "ambient temperature" or "room temperature" refers to a temperature of about 22 °C, 23 °C, 24 °C or 25 °C.

[0024] The term "halide" refers to fluoride, chloride, bromide and iodide.

[0025] The terms "biological reaction" and "biochemical reaction" are used interchangeably herein unless expressly indicated otherwise.

[0026] The present disclosure provides for preservation of biological materials, such as proteins, nucleic acids and biological samples, in substantially water-free fluid media. A biological material can be transferred from an aqueous medium to a substantially water- free fluid medium without passing through an intermediate solid state (e.g., without freezing of the aqueous medium or an aqueous organic medium), by mixing of an aqueous mixture comprising the biological material with a non-ionic organic solvent (e.g., an alcohol solvent) or an ionic organic solvent and removal of water (e.g., by evaporation) from the resulting aqueous organic mixture. To enhance, e.g., the stability and/or the solubility of the biological material in the substantially water-free fluid medium, the fluid medium can comprise a metal salt, and/or one or more substances selected from the group consisting of reducing agents, antioxidants, free radical scavengers, oxygen radical scavengers, hydroxyl radical scavengers, singlet oxygen quenchers, hydroperoxide -removing agents, protease inhibitors, nuclease inhibitors, ribonuclease (RNase) inhibitors, deoxyribonuclease (DNase) inhibitors, metal chelators, preservatives, anti-microbials, buffers (or buffering agents), detergents, and chaotropes.

[0027] The biological materials are soluble and stable in the substantially water-free fluid media at ambient temperature or higher for extended periods of time, and thus do not need to be refrigerated or frozen during shipping or storage. In addition, the biological materials retain their structural integrity, function and activity after preservation in the substantially water- free fluid media at ambient temperature or higher for extended periods of time. The biological materials retain their structural integrity, function and activity even though alcohol solvents (including polyol solvents) and ionic organic solvents (including deep eutectic solvents) comprising an organic salt and an organic hydrogen bond donor can denature biological materials such as proteins (including enzymes) and nucleic acids (including double-stranded DNA). Furthermore, the biological materials retain their structural integrity, function and activity even though removal of water from an aqueous organic mixture comprising a biological material (e.g., a protein, such as an enzyme) and a salt (e.g., an inorganic salt, such as sodium chloride) can result in, e.g., at least a 5-fold or 10-fold greater concentration of the salt in the substantially water- free fluid medium, which high salt concentration may be expected to be deleterious to the structure, function and/or activity of the biological material.

[0028] In addition to avoiding denaturation that can result from freeze-drying of biological materials, preservation of biological materials in substantially water-free fluid media can facilitate handling of the biological materials. Unlike lyophilized biological materials, because the biological materials of the present disclosure are preserved in a fluid medium, they may not need to be re- dissolved for use in fluid-phase reactions or assays, including nucleic acid amplification reactions based on PCR and analytical and diagnostic assays, such as immunoassays.

Compositions comprising a biological material in an anhydrous, non-ionic organic solvent

[0029] Some embodiments of the disclosure relate to compositions comprising a biological material in a substantially water-free, non-ionic organic solvent (e.g., an alcohol solvent). In certain embodiments, such a composition comprises:

a) a polypeptide, a polynucleotide or a biological sample, or any combination thereof,

wherein the polypeptide comprises an enzyme that mediates a nucleic acid reaction, a polypeptide that regulates an enzyme, an antibody, a polypeptide ligand of an antibody, a polypeptide aptamer, a protein or enzyme useful for detection, a toxin, a hormone, a cytokine, a polypeptide therapeutic or a vaccine, or a derivative thereof or any combination thereof;

wherein the polynucleotide comprises a polynucleotide used in a nucleic acid reaction, a catalytic polynucleotide, or a polynucleotide that binds specifically to a target ligand, or a derivative thereof or any combination thereof; and wherein the biological sample comprises a biological fluid, a biological suspension, a fluid aspirate, blood, plasma, serum, lymph, cerebrospinal fluid, gastric fluid, bile, perspiration, ocular fluid, tears, oral fluid, sputum, saliva, a buccal sample, a tonsil sample, a nasal sample, mucus, a nasopharyngeal sample, semen, urine, a vaginal sample, a cervical sample, a rectal sample, a fecal sample, a wound or purulent sample, hair, a tissue, a tissue homogenate, cells, a cellular lysate, a tissue or cell biopsy, skin cells, tumor or cancer cells, a microbe, a pathogen, a bacterium, a fungus, a protozoan or a virus, or any combination thereof; and b) at least one alcohol solvent selected from the group consisting of linear and branched C2-C6 acyclic alcohols having one or more hydroxyl groups and C3-C6 cyclic alcohols having one or more hydroxyl groups and three to six ring carbon atoms, wherein the acyclic alcohols and the cyclic alcohols optionally comprise one or more halide atoms; wherein the composition is in a fluid state and is substantially free of water.

[0030] In some embodiments, the at least one alcohol solvent in the composition comprises no more than about 20%, 15%, 10%, 5%, 4%, 3%, 2%, 1% or 0.5% water by mass relative to the combined mass of water and the at least one alcohol solvent, e.g., after storage of the composition in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 1.5 years or 2 years. In certain embodiments, the at least one alcohol solvent in the composition comprises no more than about 10%, 5% or 1%> water by mass relative to the combined mass of water and the at least one alcohol solvent, e.g., after storage of the composition in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 1.5 years or 2 years. In some embodiments, the at least one alcohol solvent in the composition comprises no more than about 10%>, 5% or 1% water by mass relative to the combined mass of water and the at least one alcohol solvent after storage of the composition in a closed container (e.g., a capped tube, vial or well) at ambient temperature for at least about 3 months or 6 months.

[0031] In further embodiments, the at least one alcohol solvent is substantially soluble in water - e.g., at least about 50%, 60%, 70%, 80%, 90%, 95% or 99% of the at least one alcohol solvent by mass or volume is soluble in water. In certain embodiments, at least about 90%, 95% or 99% of the at least one alcohol solvent by mass or volume is soluble in water. In an embodiment, the at least one alcohol solvent is miscible with water. Solubility of the at least one alcohol solvent in water promotes transfer of a biological material from an aqueous medium to the at least one alcohol solvent.

[0032] In yet further embodiments, the at least one alcohol solvent has a boiling point substantially greater than that of water - e.g., a boiling point at least or greater than about 110 °C, 125 °C, 150 °C, 175 °C, 200 °C or 250 °C at a pressure of about 1 atmosphere (atm). In certain embodiments, the at least one alcohol solvent has a boiling point at least or greater than about 150 °C, 175 °C or 200 °C at a pressure of about 1 atm. The at least one alcohol solvent having a boiling point greater than the boiling point of water allows for an aqueous mixture comprising a biological material to be mixed with at least one alcohol solvent and for water to be selectively removed (e.g., by evaporation) from the resulting aqueous organic mixture without substantial loss of the at least one alcohol solvent.

[0033] In additional embodiments, the at least one alcohol solvent has a dynamic (or absolute) viscosity of no more than about 1500, 1000, 500, 400, 300, 200, 100, 50 or 25 centipoise (cP) or mPa-s at ambient temperature. In certain embodiments, the at least one alcohol solvent has a dynamic (or absolute) viscosity of no more than about 1000, 500, 200, 100 or 50 cP or mPa-s at ambient temperature. A lower dynamic (or absolute) viscosity of the at least one alcohol solvent allows for more facile handling of the composition comprising the biological material and the at least one alcohol solvent (e.g., using a pipette or other means of transferring the fluid composition).

[0034] In some embodiments, the linear and branched C₂-C₆ acyclic alcohols having one or more hydroxyl groups and optionally comprising one or more halide atoms are linear and branched C₂-C₅ acyclic alcohols having one hydroxyl group and optionally comprising one or more halide atoms. Non-limiting examples of linear and branched C₂-C₅ acyclic alcohols having one hydroxyl group and optionally comprising one or more halide atoms include 2-chloroethanol, 2,2-dichloroethanol, 1 - butanol, 1 -pentanol, 2-methylbutan-l -ol, 3-methylbutan-l -ol, 2,2-dimethylpropan-l -ol, 2-pentanol, 3- methylbutan-2-ol, and 3-pentanol.

[0035] In other embodiments, the linear and branched C₂-C₆ acyclic alcohols are linear and branched C2-C6 acyclic alcohols having two or more (e.g., two or three) hydroxyl groups and optionally comprising one or more halide atoms. Non-limiting examples of linear and branched C₂- Ce acyclic alcohols having two or more (e.g., two or three) hydroxyl groups and optionally comprising one or more halide atoms include 1 ,2-ethanediol (ethylene glycol), 1 ,2-propanediol (propylene glycol), 1 ,3 -propanediol, 1 ,2,3-propanetriol (glycerol), 1 ,2-butanediol, 1 ,3-butanediol, 1 ,4-butanediol, 2,3-butanediol, 1 ,2,3-butanetriol, 1 ,2,4-butanetriol, 1 ,2-pentanediol, 1 ,3-pentanediol, 1 ,4-pentanediol, 1 ,5-pentanediol, 2,3-pentanediol, 2,4-pentanediol, 1 ,2,3-pentanetriol, 1 ,2,4-pentanetriol, 1 ,2,5- pentanetriol, 1 ,3,4-pentanetriol, 1 ,3,5-pentanetriol, 2,3,4-pentanetriol, 1 ,2-hexanediol, 1 ,3- hexanediol, 1 ,4-hexanediol, 1 ,5-hexanediol, 2,3-hexanediol, 2,4-hexanediol, 2,5-hexanediol, 3,4- hexanediol, di(ethylene glycol), and tri(ethylene glycol).

[0036] In certain embodiments, the linear and branched C₂-C₆ acyclic alcohols are linear and branched C₂-C₅ acyclic alcohols having two or more (e.g., two or three) hydroxyl groups and optionally comprising one or more halide atoms. In some embodiments, the at least one alcohol solvent comprises ethylene glycol, 1 ,2-propanediol, 1 ,3-propanediol, glycerol, 1 ,2-butanediol, 1,3- butanediol, 1 ,4-butanediol, 2,3-butanediol, 1 ,2,4-butanetriol or 1 ,5-pentanediol, or any combination thereof. In certain embodiments, the at least one alcohol solvent comprises ethylene glycol, 1 ,3- propanediol, glycerol or 1 ,2-butanediol, or any combination thereof.

[0037] In some embodiments, the C₃-C₆ cyclic alcohols having one or more hydroxyl groups and optionally comprising one or more halide atoms are C4 or C₅ cyclic alcohols having one or more hydroxyl groups and four or five ring carbon atoms and optionally comprising one or more halide atoms. In certain embodiments, the at least one alcohol solvent comprises cyclobutanol or cyclopentanol, or both.

[0038] In some embodiments, the at least one alcohol solvent comprises two or more alcohol solvents. In certain embodiments, the at least one alcohol solvent comprises two or more alcohol solvents selected from the group consisting of ethylene glycol, 1 ,2-propanediol, 1 ,3-propanediol, glycerol, 1 ,2-butanediol, 1 ,3-butanediol, 1 ,4-butanediol, 2,3-butanediol, 1 ,2,4-butanetriol, and 1 ,5- pentanediol. In additional embodiments, the at least one alcohol solvent comprises: (a) ethylene glycol and glycerol; or (b) ethylene glycol and 1 ,2-butanediol; or (c) glycerol and 1 ,2-butanediol. In further embodiments, the at least one alcohol solvent comprises glycerol and an additional alcohol solvent that can be any alcohol solvent described herein. In certain embodiments, the at least one alcohol solvent comprises glycerol and an additional alcohol solvent selected from the group consisting of ethylene glycol, 1 ,2-propanediol, 1,3-propanediol, 1 ,2-butanediol, 1,3-butanediol, 1,4- butanediol, 2,3-butanediol, 1,2,3-butanetriol, 1 ,2,4-butanetriol, 1 ,2-pentanediol, 1,3-pentanediol, 1,4- pentanediol, 1,5-pentanediol, 2,3-pentanediol, 2,4-pentanediol, 1,2,3-pentanetriol, 1 ,2,4-pentanetriol, 1,2,5-pentanetriol, 1,3,4-pentanetriol, 1,3,5-pentanetriol, 2,3,4-pentanetriol, 1 ,2-hexanediol, 1,3- hexanediol, 1 ,4-hexanediol, 1,5-hexanediol, 2,3-hexanediol, 2,4-hexanediol, 2,5-hexanediol, 3,4- hexanediol, di(ethylene glycol), and tri(ethylene glycol).

[0039] In some embodiments, the composition comprises an enzyme. In certain embodiments, the enzyme mediates a nucleic acid reaction. In some embodiments, the enzyme that mediates a nucleic acid reaction comprises a topoisomerase, a helicase, a DNA polymerase, a reverse transcriptase, an RNA polymerase, a DNA ligase, an RNA ligase, a DNA repair enzyme, an RNA repair enzyme, an endonuclease, an exonuclease, a deoxyribonuclease (DNase), a ribonuclease (RNase), a transposase, a restriction enzyme or a nicking enzyme, or any combination thereof. In further embodiments, the enzyme that mediates a nucleic acid reaction comprises a DNA polymerase, a reverse transcriptase or an RNA polymerase, or any combination thereof. In certain embodiments, the enzyme that mediates a nucleic acid reaction comprises a DNA polymerase (e.g., a heat-stable DNA polymerase, such as a Taq polymerase) used in PCR or a reverse transcriptase used in PCR, or both.

[0040] Polymerase chain reaction (PCR) includes standard PCR and variations thereof, such as allele-specific PCR, assembly PCR, asymmetric PCR, dial-out PCR, hot-start PCR, intersequence- specific PCR, inverse PCR, isothermal PCR (e.g., helicase-dependent amplification and PAN-AC), ligation-mediated PCR, methylation-specific PCR, mini-primer PCR, multiplex ligation-dependent probe amplification, multiplex PCR, nested PCR, overlap-extension PCR, picotiter PCR, quantitative PCR, real-time PCR, restriction fragment length polymorphism PCR, reverse transcription PCR (RT- PCR), single-cell PCR, solid-phase PCR (e.g., standard solid-phase PCR, enhanced solid-phase PCR, bridge PCR, and polony amplification), thermal asymmetric interlaced PCR, touchdown (step-down) PCR, and universal fast walking PCR.

[0041] In further embodiments, the composition comprises a polynucleotide used in a nucleic acid reaction. In some embodiments, the polynucleotide comprises at least one primer used in PCR or reverse transcription. In certain embodiments, the at least one primer used in PCR or reverse transcription comprises at least one pair of a forward primer and a reverse primer for amplifying at least one nucleic acid (e.g., genetic) locus, or at least one reverse transcription primer for reverse transcribing at least one polyribonucleotide, or both. In some embodiments, the at least one pair of forward primer and reverse primer is labeled with a dye (e.g., a fluorescent dye) or the at least one reverse transcription primer is labeled with a dye (e.g., a fluorescent dye), or both. [0042] In some embodiments, the composition comprises a plurality of different pairs of forward and reverse primers for amplifying a plurality of different short tandem repeat (STR) loci utilized in a forensic database, such as the Combined DNA Index System (CODIS) recommended by the Federal Bureau of Investigation (FBI). CODIS presently utilizes 13 STR loci dubbed CSF1PO, D3S1358, D5S818, D7S820, D8S1179, D13S317, D16S539, D18S51, D21 S11, FGA, TH01, TPOX and vWA. In certain embodiments, the composition comprises at least 5 or at least 10, or 13, different pairs of forward and reverse primers for amplifying at least 5 or at least 10, or all 13, CODIS STR loci. In further embodiments, the composition further comprises at least one pair of forward and reverse primers for amplifying at least one other STR locus useful for human identification, such as Penta D and Penta E. In additional embodiments, the composition further comprises at least one pair of forward and reverse primers for amplifying at least one nucleic acid (e.g., genetic) locus useful for sex determination, such as amelogenin (AMEL). In certain embodiments, the composition comprises 16 different pairs of forward and reverse primers for amplifying all 13 CODIS STR loci, Penta D, Penta E and amelogenin. In some embodiments, each of the 16 different pairs of forward and reverse primers is labeled with a dye (e.g., a fluorescent dye), which may be the same as or different from the dyes used to label the other pairs of forward and reverse primers (e.g., three, four or more spectrally resolvable fluorescent dyes can be used to label the 16 different pairs of forward and reverse primers).

[0043] In additional embodiments, the composition comprises one or more reagents for performing PCR, wherein the reagents for performing PCR comprise a DNA polymerase and at least one pair of a forward primer and a reverse primer for amplifying at least one nucleic acid (e.g., genetic) locus, and the at least one pair of forward primer and reverse primer optionally is labeled with a dye (e.g., a fluorescent dye). In some embodiments, the at least one pair of forward and reverse primers comprises at least 5 or 10 different pairs of forward and reverse primers for amplifying at least 5 or 10 different STR loci utilized in a forensic database (e.g., CODIS), wherein each of the at least 5 or 10 different pairs of forward and reverse primers optionally is labeled with a dye (e.g., a fluorescent dye). In certain embodiments, the at least one pair of forward and reverse primers comprises 16 different pairs of forward and reverse primers for amplifying all 13 CODIS STR loci, Penta D, Penta E and amelogenin. In some embodiments, each of the 16 different pairs of forward and reverse primers is labeled with a dye (e.g., a fluorescent dye), which may be the same as or different from the dyes used to label the other pairs of forward and reverse primers (e.g., three, four or more spectrally resolvable fluorescent dyes can be used to label the 16 different pairs of forward and reverse primers). In certain embodiments, the DNA polymerase comprises a DNA polymerase that is stable at elevated temperature (e.g., at about 60 °C, 70 °C, 80 °C, 90 °C or higher), such as a Taq polymerase. In further embodiments, the reagents for performing PCR further comprise deoxyribonucleotide triphosphates. In additional embodiments, the reagents for performing PCR further comprise a buffer or a metal salt (e.g., an M⁺¹ or M⁺² salt, such as magnesium chloride), or both.

[0044] In some embodiments, the composition comprises the DNA polymerase, the at least one pair of forward and reverse primers, deoxyribonucleotide triphosphates, and optionally a buffer and/or a metal salt (e.g., an M⁺¹ or M⁺² salt, such as magnesium chloride) for performing PCR. In other embodiments, the composition comprises the DNA polymerase and no primer, where the composition can further comprise deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., an M⁺¹ or M⁺² salt, such as magnesium chloride). In yet other embodiments, the composition comprises the at least one pair of forward and reverse primers and no DNA polymerase, where the composition can further comprise deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., an M⁺¹ or M⁺² salt, such as magnesium chloride). A kit containing reagents for performing PCR can contain, for example:

1) a composition comprising the DNA polymerase, the at least one pair of forward and reverse primers, deoxyribonucleotide triphosphates, and optionally a buffer and/or a metal salt; or

2) (i) a composition comprising the DNA polymerase and no primer, which can further comprise deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt; and

(ii) a separate composition comprising the at least one pair of forward and reverse primers and no DNA polymerase, which can further comprise deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt.

[0045] In some embodiments, the composition comprises one or more PCR reagents for amplifying at least one nucleic acid (e.g., genetic) sequence of the DNA of a microbe or a pathogen, such as the DNA of any bacterium described herein, the DNA of any fungus described herein, and the DNA of any DNA virus described herein. A kit can contain a composition comprising all of the PCR reagents for amplifying at least one nucleic acid (e.g., genetic) sequence of the DNA of a microbe or a pathogen, or two or more compositions that in total comprise all of the PCR reagents.

[0046] In other embodiments, the composition comprises one or more reagents for performing reverse transcription, wherein the reagents for performing reverse transcription comprise a reverse transcriptase and at least one reverse transcription primer for reverse transcribing at least one polyribonucleotide, and the at least one reverse transcription primer optionally is labeled with a dye (e.g., a fluorescent dye). In further embodiments, the reagents for performing reverse transcription further comprise deoxyribonucleotide triphosphates. In additional embodiments, the reagents for performing reverse transcription further comprise a buffer or a metal salt (e.g., an M⁺¹ or M⁺² salt, such as magnesium chloride), or both.

[0047] In some embodiments, the composition comprises the reverse transcriptase, the at least one reverse transcription primer, deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., an M⁺¹ or M⁺² salt, such as magnesium chloride) for performing reverse transcription. In other embodiments, the composition comprises the reverse transcriptase and no reverse

transcription primer, where the composition can further comprise deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., an M⁺¹ or M⁺² salt, such as magnesium chloride). In yet other embodiments, the composition comprises the at least one reverse transcription primer and no reverse transcriptase, where the composition can further comprise deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., an M⁺¹ or M⁺² salt, such as magnesium chloride). A kit containing reagents for performing reverse transcription can contain, for example: 1) a

composition comprising the reverse transcriptase, the at least one reverse transcription primer, deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt; or 2) (i) a composition comprising the reverse transcriptase and no reverse transcription primer, which can further comprise deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt; and (ii) a separate composition comprising the at least one reverse transcription primer and no reverse transcriptase, which can further comprise deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt.

[0048] In further embodiments, the composition comprises one or more reagents for performing reverse transcription PCR (RT-PCR), wherein: the reagents for performing RT-PCR comprise a reverse transcriptase, a DNA polymerase, at least one reverse transcription primer for reverse transcribing at least one polyribonucleotide to produce at least one polydeoxyribonucleotide complementary to the at least one polyribonucleotide, and at least one pair of a forward primer and a reverse primer for amplifying the at least one complementary polydeoxyribonucleotide; and the at least one reverse transcription primer optionally is labeled with a dye (e.g., a fluorescent dye) and the at least one pair of forward primer and reverse primer optionally is labeled with a dye (e.g., a fluorescent dye).

[0049] In certain embodiments, the DNA polymerase comprises a DNA polymerase that is stable at elevated temperature (e.g., at about 60 °C, 70 °C, 80 °C, 90 °C or higher), such as a Taq polymerase. In additional embodiments, the reagents for performing RT-PCR further comprise

deoxyribonucleotide triphosphates. In certain embodiments, the reagents for performing RT-PCR further comprise a buffer or a metal salt (e.g., an M⁺¹ or M⁺² salt, such as magnesium chloride), or both.

[0050] In some embodiments, the composition comprises the reverse transcriptase, the DNA polymerase, the at least one reverse transcription primer, the at least one pair of forward and reverse primers, deoxyribonucleotide triphosphates, and optionally a buffer and/or a metal salt (e.g., an M⁺¹ or M⁺² salt, such as magnesium chloride) for performing RT-PCR. In other embodiments, the composition comprises the reverse transcriptase, the DNA polymerase, no reverse transcription primer, and no pair of forward and reverse primers, where the composition can further comprise deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., an M⁺¹ or M⁺² salt, such as magnesium chloride). In yet other embodiments, the composition comprises the at least one reverse transcription primer, the at least one pair of forward and reverse primers, no reverse transcriptase, and no DNA polymerase , where the composition can further comprise

deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., an M⁺¹ or M⁺² salt, such as magnesium chloride). A kit containing reagents for performing RT-PCR can contain, for example: 1) a composition comprising the reverse transcriptase, the DNA polymerase, the at least one reverse transcription primer, the at least one pair of forward and reverse primers, deoxyribonucleotide triphosphates, and optionally a buffer and/or a metal salt; or 2) (i) a composition comprising the reverse transcriptase, the DNA polymerase, no reverse transcription primer, and no pair of forward and reverse primers, which can further comprise deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt; and (ii) a separate composition comprising the at least one reverse transcription primer, the at least one pair of forward and reverse primers, no reverse transcriptase, and no DNA polymerase , which can further comprise deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt.

[0051] In some embodiments, the composition comprises one or more RT-PCR reagents for amplifying at least one polydeoxyribonucleotide complementary to at least one nucleic acid (e.g., genetic) sequence of the RNA of an RNA virus, such as the RNA of any RNA virus described herein. A kit can contain a composition comprising all of the RT-PCR reagents for amplifying at least one polydeoxyribonucleotide complementary to at least one nucleic acid (e.g., genetic) sequence of the RNA of an RNA virus, or two or more compositions that in total comprise all of the RT-PCR reagents.

[0052] In additional embodiments, the composition comprises reagents for performing transcription, wherein the reagents for performing transcription comprise an RNA polymerase. In further embodiments, the reagents for performing transcription further comprise ribonucleotide triphosphates. In certain embodiments, the reagents for performing transcription further comprise a buffer or a metal salt (e.g., an M⁺¹ or M⁺² salt, such as magnesium chloride), or both.

[0053] In further embodiments, the composition comprises a polypeptide that regulates (e.g., agonizes or antagonizes/inhibits) an enzyme. Non-limiting examples of polypeptides that regulate enzymes include polypeptides that inhibit proteases, such as the protease inhibitors described herein.

[0054] In other embodiments, the composition comprises an antibody. In some embodiments, the antibody is used in an immunoassay. In certain embodiments, the immunoassay is an enzyme- linked immunosorbent assay (ELISA) or a sandwich immunoassay. In further embodiments, the antibody used in an immunoassay comprises an unlinked antibody, an antibody bound to a solid substrate (e.g., a bead), an antibody conjugated to a detection protein or enzyme or a fragment thereof, or any combination thereof, wherein the antibody may or may not be labeled with a dye (e.g., a fluorescent dye, a chemiluminescent dye, or a phosphorescent dye). [0055] In some embodiments, the composition comprises one or more reagents for performing an immunoassay, wherein the one or more reagents for performing an immunoassay comprise an antibody that has affinity for or is specific for a target antigen or analyte, the antibody is labeled with a dye (e.g., a fluorescent dye, a chemiluminescent dye, or a phosphorescent dye) or is conjugated to a detection protein or enzyme or a fragment thereof, and the antibody optionally is bound to a solid substrate (e.g., a bead).

[0056] In further embodiments, the composition comprises one or more reagents for performing a sandwich immunoassay, wherein: the reagents for performing a sandwich immunoassay comprise a first antibody that has affinity for or is specific for a target antigen or analyte and a second antibody that has affinity for or is specific for the target antigen or analyte; the second antibody is labeled with a dye (e.g., a fluorescent dye, a chemiluminescent dye, or a phosphorescent dye) or is conjugated to a detection protein or enzyme or a fragment thereof; and the first antibody optionally is bound to a solid substrate (e.g., a bead).

[0057] In some embodiments, the composition comprises the first antibody and the second antibody. In other embodiments, the composition comprises the first antibody and not the second antibody. In yet other embodiments, the composition comprises the second antibody and not the first antibody. A kit containing reagents for performing a sandwich immunoassay can contain, for example: 1) a composition comprising the first antibody and the second antibody; or 2) (i) a composition comprising the first antibody and not the second antibody; and (ii) a separate composition comprising the second antibody and not the first antibody.

[0058] In additional embodiments, the composition comprises one or more reagents for performing an enzyme-linked immunosorbent assay (ELISA), wherein the reagents for performing ELISA comprise: a detection antibody that has affinity for or is specific for a target antigen or analyte and is conjugated to a detection enzyme or a fragment thereof; or a first antibody that has affinity for or is specific for a target antigen or analyte, and a second antibody that has affinity for or is specific for the first antibody and is conjugated to a detection enzyme or a fragment thereof.

[0059] In some embodiments, the composition comprises the detection antibody. In other embodiments, the composition comprises the first antibody and the second antibody. In yet other embodiments, the composition comprises the first antibody and not the second antibody. In still other embodiments, the composition comprises the second antibody and not the first antibody. A kit containing reagents for performing an ELISA can contain, for example: 1) a composition comprising the detection antibody; or 2) a composition comprising the first antibody and the second antibody; or 3) (i) a composition comprising the first antibody and not the second antibody; and (ii) a separate composition comprising the second antibody and not the first antibody.

[0060] The detection protein or enzyme or a fragment thereof that is conjugated to an antibody used in an immunoassay can be any protein or enzyme or any fragment thereof that is suitable for detection. In certain embodiments, the detection protein or enzyme or a fragment thereof that is conjugated to an antibody used in an immunoassay is selected from the group consisting of: a) phycobiliproteins, phycoerythrins, B-phycoerythrin, R-phycoerythrin, and fragments and conjugates thereof; b) streptavidin, avidin, deglycosylated avidin, and fragments and conjugates thereof; c) peroxidases, horseradish peroxidase, and fragments and conjugates thereof; and d) phosphatases, alkaline phosphatase, and fragments and conjugates thereof.

[0061] In further embodiments, the composition comprises a protein or enzyme useful for detection, where the protein or enzyme may or may not be conjugated to an antibody. Non-limiting examples of proteins and enzymes useful for detection include: a) phycobiliproteins, phycoerythrins, B-phycoerythrin, R-phycoerythrin, and conjugates thereof (e.g., phycoerythrin-streptavidin conjugates, phycoerythrin-alkaline phosphatase conjugates, and phycoerythrin-antibody conjugates); b) streptavidin, avidin, deglycosylated avidin, and conjugates thereof (e.g., streptavidin-horse radish peroxidase conjugates and streptavidin-antibody conjugates); c) peroxidases, horseradish peroxidase, and conjugates thereof (e.g., horseradish peroxidase-antibody conjugates); and d) phosphatases, alkaline phosphatase, and conjugates thereof (e.g., alkaline phosphatase-antibody conjugates).

[0062] In additional embodiments, the composition comprises a polypeptide aptamer that binds specifically to a target ligand (e.g., a small molecule, a protein, a nucleic acid, a cell, a tissue or an organism). In some embodiments, the polypeptide aptamer comprises a variable domain or loop (e.g., a domain or loop containing about 10 to about 20 amino acids) attached at both ends to a polypeptide scaffold (e.g., a protein scaffold, such as thioredoxin A).

[0063] The composition can also contain other kinds of polypeptides, including without limitation receptors (e.g., peripheral membrane proteins, transmembrane proteins and nuclear receptors), polypeptide ligands (e.g., polypeptide ligands of antibodies), regulatory factors, hormones, cytokines (e.g., interferons and inter leukins), structural proteins (e.g., collagen and elastin), and toxins. Non-limiting examples of hormones include adrenocorticotropic hormone, angiotensin II, antidiuretic hormone (vasopressin), basic fibroblast growth factor-2, cholecystokinin, colony- stimulating factors (e.g., granulocyte colony-stimulating factor), gastrin, growth hormone, insulin, leptin, atrial natriuretic peptide, brain natriuretic peptide, C-type natriuretic peptide, oxytocin, parathyroid hormone -related protein, prolactin, and somatostatin. Examples of toxins include without limitation cyanotoxins, cytotoxins, exotoxins (e.g., botulinum toxin and Corynebacterium diphtheriae exotoxin), hemotoxins, hepatotoxins (e.g., amatoxins and phallotoxins), mycotoxins, necrotoxins, neurotoxins (e.g., bungarotoxins, chlorotoxin, conotoxins and tetanus toxin), plant toxins (e.g., ricin), insect toxins (e.g., apitoxin), and snake toxins [e.g., cardiotoxins, myotoxins, neurotoxins (such as alpha-neurotoxins, beta-neurotoxins and dendrotoxins), sarafotoxins, hydrolases (such as

phosphodiesterases and phospholipases), lyases, oxydoreductases (such as L-amino acid oxidases), transferases, hemorrhagins, hyaluronidases, thrombin-like pro-coagulants, and kallikrein-like serine proteases].

[0064] Furthermore, the composition can preserve polypeptide therapeutics (e.g., hormone therapeutics, cytokine therapeutics, antibody therapeutics, fusion protein therapeutics,

antithrombotics, and toxin therapeutics) and vaccines in a substantially water-free fluid medium, e.g., without the need for refrigeration. Hormone therapeutics include without limitation erythropoietin, growth hormone, insulin, and other hormones described herein. Cytokine therapeutics include without limitation interferons [e.g., interferon alpha (including interferon alpha-2a and interferon alpha-2b), interferon beta (including interferon beta-la and interferon beta-lb), and derivatives thereof (including interferons derivatived with polyethylene glycol (PEG))] and interleukins (e.g., interleukin 2 and interleukin 12). Non- limiting examples of antibody therapeutics include adalimumab, bevacizumab, infliximab, trastuzumab, and ustekinumab. Fusion protein therapeutics include without limitation abatacept, alefacept, denileukin diftitox, and etanercept. Non-limiting examples of antithrombotics include anti-platelet agents (e.g., abciximab), anticoagulants (e.g., antithrombin, batroxobin, hementin, hirudin, lepirudin and bivalirudin), and thrombolytics [e.g., tissue plasminogen activators (including alteplase, reteplase and tenecteplase), anistreplase, streptokinase and urokinase]. Examples of toxin therapeutics include without limitation botulinum toxin, chlorotoxin, and toxoids used as vaccines (e.g., against botulism, diphtheria and tetanus). Non- limiting examples of vaccines include vaccines against botulism, bubonic plague, chicken pox, cholera, diphtheria, hepatitis, influenza, measles, mumps, polio, rabies, rubella, small pox, tetanus, tuberculosis, typhoid, and yellow fever.

[0065] In some embodiments, the composition contains a pharmaceutical formulation comprising a polypeptide and optionally one or more other substances as described herein. In certain

embodiments, the concentration of the polypeptide in the composition is at least about 10 mg/mL, 50 mg/mL, 100 mg/mL, 200 mg/mL, 300 mg/mL, 400 mg/mL, 500 mg/mL or 1 g/mL, or about 100- 1000 mg/mL, 100-500 mg/mL or 500-1000 mg/mL. In some embodiments, the concentration of the polypeptide in the composition is at least about 100 mg/mL, or about 100-1000 mg/mL.

[0066] In further embodiments, the composition comprises a catalytic polynucleotide. In some embodiments, the catalytic polynucleotide is a natural or synthetic ribozyme (or RNA enzyme or catalytic RNA). Non- limiting examples of natural ribozymes include peptidyl transferase 23 S rRNA, RNase P, Group I introns, Group II introns, GIR1 branching ribozyme, leadzyme, hairpin ribozyme, hammerhead ribozyme, HDV ribozyme, mammalian CPEB3 ribozyme, VS ribozyme, glmS ribozyme, and CoTC ribozyme. Examples of synthetic ribozymes include without limitation ribozymes produced from RNA polymerases (e.g., Round 18 RNA polymerase ribozyme and variants thereof, such as B6.61 ribozyme and tC19Z ribozyme) and ribozymes produced from RNA ligases. In other embodiments, the catalytic polynucleotide is a deoxyribozyme (or DNA enzyme or catalytic DNA), including deoxyribozymes that catalyze DNA phosphorylation, DNA adenylation, DNA deglycosylation, DNA cleavage, thymine dimer photoreversion, and porphyrin metalation.

[0067] In additional embodiments, the composition comprises a polynucleotide that binds specifically to a target ligand (e.g., a small molecule, a protein, a nucleic acid, a cell, a tissue or an organism). In some embodiments, the polynucleotide that binds specifically to a target ligand is a natural or synthetic nucleic acid aptamer (e.g., DNA aptamer, RNA aptamer or XNA aptamer). Non- limiting examples of nucleic acid aptamers include DNA aptamers and RNA aptamers that bind dopamine, hemin, HIV trans-acting responsive element, interferons (e.g., interferon-gamma), lysozymes, mycotoxins, thrombin, and vascular endothelial growth factor (VEGF).

[0068] In other embodiments, the composition comprises a biological sample. The biological sample can be, e.g., a clinical sample, a surgical sample, a laboratory sample, a research sample, a forensic sample, a veterinary sample, an environmental sample, an agricultural sample, or an industrial sample. The biological sample can be re-hydrated by addition of water or an aqueous solution (e.g., an aqueous buffer) for analysis, if desired. In some embodiments, the biological sample comprises whole or fractionated animal (e.g., mammalian, such as human) blood. In further embodiments, the biological sample comprises whole or fractionated animal (e.g., mammalian, such as human) plasma. In still further embodiments, the biological sample comprises whole or fractionated animal (e.g., mammalian, such as human) serum.

[0069] In additional embodiments, the biological sample comprises cells. A cell can be, e.g., a eukaryotic or prokaryotic cell from any single-celled or multi-celled organism, and can be of any type. In some embodiments, the biological sample comprises animal cells, mammalian cells, human cells, plant cells, microbial cells, pathogenic cells, bacterial cells, fungal cells, protozoan cells or viral particles, or any combination thereof, or lysates or extracts thereof. The cells or viral particles can be dissolved or suspended in a natural fluid or a laboratory culture medium (e.g., Dulbecco's phosphate buffered saline with 2% fetal bovine serum, Eagle's minimum essential medium (EMEM), Dulbecco's modified Eagle's medium (DMEM), or the allantoic fluid of embryonated chicken eggs) and then transferred to the substantially water- free fluid medium containing the at least one alcohol solvent (or the at least one ionic organic solvent in other embodiments of a composition comprising a biological material in a substantially water- free fluid medium, as described below).

[0070] In some embodiments, the biological sample comprises a bacterium. The bacterium can be non-pathogenic or pathogenic. Non- limiting examples of bacteria include Bacillus (e.g., Bacillus anthracis, Bacillus cereus and Bacillus thuringiensis); Bordetella (e.g., Bordetella pertussis); Borrelia (e.g., Borrelia burgdorferi); Brucella (e.g., Brucella abortus, Brucella canis, Brucella melitensis, and Brucella suis); Campylobacter (e.g., Campylobacter jejuni); Chlamydia and Chlamydophila (e.g., Chlamydia pneumoniae, Chlamydia trachomatis, and Chlamydophila psittaci); Clostridium (e.g., Clostridium botulinum, Clostridium difficile, Clostridium perfringens, and Clostridium tetani);

Corynebacterium (e.g., Corynebacterium diphtheriae); Enterococcus (e.g., Enterococcus faecalis and Enterococcus faecium); Escherichia (e.g., Escherichia coli); Francisella (e.g., Francisella tularensis); Haemophilus (e.g., Haemophilus influenzae); Helicobacter (e.g., Helicobacter pylori); Legionella (e.g., Legionella pneumophila); Leptospira (e.g., Leptospira interrogans); Listeria (e.g., Listeria monocytogenes); Mycobacterium (e.g., Mycobacterium leprae, Mycobacterium tuberculosis, and Mycobacterium ulcerans); Mycoplasma (e.g., Mycoplasma pneumoniae); Neisseria (e.g., Neisseria gonorrhoeae and Neisseria meningitidis); Pseudomonas (e.g., Pseudomonas aeruginosa); Rickettsia (e.g., Rickettsia rickettsu); Salmonella (e.g., Salmonella typhi and Salmonella typhimurium); Shigella (e.g., Shigella sonnei); Staphylococcus (e.g., Staphylococcus aureus, Staphylococcus epidermidis, and Staphylococcus saprophytics); Streptococcus (e.g., Streptococcus agalactiae, Streptococcus pneumoniae, and Streptococcus pyogenes); Treponema (e.g., Treponema pallidum); Vibrio (e.g., Vibrio cholerae and Vibrio parahaemolyticus); and Yersinia (e.g., Yersinia pestis).

[0071] In other embodiments, the biological sample comprises a fungus. The fungus can be nonpathogenic or pathogenic. Examples of fungi include without limitation Aspergillus (e.g., Aspergillus clavatus, Aspergillus fumigatus, and Aspergillus flavus); Blastomyces (e.g., Blastomyces

dermatitidis); Candida (e.g., Candida albicans); Coccidioides (e.g., Coccidioides immitis and

Coccidioides posadasii); Cryptococcus (e.g., Cryptococcus albidus, Cryptococcus gattii,

Cryptococcus laurentii, and Cryptococcus neoformans); Fusarium (e.g., Fusarium graminearum, Fusarium oxysporum, Fusarium proliferatum, Fusarium solani complex, and Fusarium

verticillioides); Histoplasma (e.g., Histoplasma capsulatum); Pneumocystis [e.g., Pneumocystis jirovecii (or Pneumocystis carinii)]; Stachybotrys (e.g., Stachybotrys chartarum); Trichosporon (e.g., Trichosporon asahii, Trichosporon asteroides, Trichosporon cutaneum, Trichosporon dermatis, Trichosporon dohaense, Trichosporon inkin, Trichosporon loubieri, Trichosporon mucoides and Trichosporon ovoides); and Zygomycetes (e.g., Rhizopus stolonifer).

[0072] In yet other embodiments, the biological sample comprises a protozoan. The protozoan can be non-pathogenic or pathogenic. Examples of protozoa include without limitation Balantidium (e.g., Balantidium coli); Cryptosporidium (e.g., Cryptosporidium canis, Cryptosporidium felis, Cryptosporidium hominis, Cryptosporidium meleagridis, Cryptosporidium muris and

Cryptosporidium parvum); Entamoeba (e.g., Entamoeba dispar and Entamoeba histolytica); Giardia (e.g., Giardia lamblia and Giardia muris); Leishmania (e.g., Leishmania braziliensis, Leishmania infantum and Leishmania major); Naegleria (e.g., Naegleria fowleri); Plasmodia (e.g., Plasmodia falciparum, Plasmodia knowlesi, Plasmodia malariae and Plasmodia vivax); Toxoplasma (e.g., Toxoplasma gondii); Trichomonas (e.g., Trichomonas vaginalis); and Trypanosoma (e.g.,

Trypanosoma brucei and Trypanosoma cruzi). [0073] In additional embodiments, the biological sample comprises a viras. The viras can be a DNA viras or an RNA virus. Non- limiting examples of DNA viruses include adenoviruses [including Atadenovirus (e.g., ovine adenovirus D), Aviadenovirus (e.g., fowl adenovirus A), Ichtadenovirus (e.g., sturgeon adenovirus A), Mastadenovirus (e.g., human adenovirus C and AD-36), and

Siadenovirus (e.g., frog adenovirus)] ; hepadnavirases [including Orthohepadnavirus (e.g., hepatitis B virus) and Avihepadnavirus (e.g., duck hepatitis B virus)]; herpesviruses [including human herpesviruses (e.g., herpes simplex virus-1 , herpes simplex viras-2, Varicella zoster viras, Epstein- Barr viras, cytomegalovirus, roseoloviras, herpes lymphotropic virus, pityriasis rosea viras, and Kaposi's sarcoma-associated herpesvirus) and zoonotic herpesviruses (e.g., cercopithecine herpesvirus-1 and murine gammaherpesviras-68)]; papillomaviruses (e.g., human papillomaviruses 1 to 18); and polyomaviruses [including Orthopolyomavirus (e.g., simian virus 40, B -lymphotropic polyomaviras, baboon polyomaviras 1 , bat polyomavirus, BK polyomaviras, Bornean orang-utan polyomaviras, Sumatran orang-utan polyomavirus, bovine polyomaviras, California sea lion polyomaviras, chimpanzee polyomaviras, hamster polyomaviras, JC polyomavirus, Merkel cell polyomaviras, murine pneumotropic viras, murine polyomavirus, squirrel monkey polyomaviras, and trichodysplasia spinuolsa-associated polyomavirus), Wukipolyomavirus (e.g., human polyomaviruses 6 and 7, KI polyomavirus, and WU polyomavirus), Avipolyomavirus (e.g., avian polyomaviras, canary polyomavirus, crow polyomaviras, finch polyomaviras, and goose hemorrhagic

polyomaviras), and human polyomavirus 9].

[0074] Non-limiting examples of RNA viruses include coronaviruses [including human coronaviruses (e.g., SARS coronavirus)]; flavivirases [including Flavivirus (e.g., yellow fever viras, West Nile viras, and dengue fever viras), Hepacivirus (e.g., hepatitis C virus), Hepatitis G Virus (e.g., the GB agent and hepatitis G viras), and Pestivirus (e.g., bovine viral diarrhea viras, classical swine fever virus, and hog cholera virus)]; orthomyxoviruses [including Influenzavirus A (e.g., influenza A virus), Influenzavirus B (e.g., influenza B viras), Influenzavirus C (e.g., influenza C virus), Isavirus (e.g., infectious salmon anemia viras), and Thogotovirus (e.g., Dhori virus and Thogoto virus)] ;

paramyxoviruses [including Aquaparamyxovirus (e.g., Atlantic salmon paramyxovirus and Pacific salmon paramyxovirus), Avulavirus (e.g., Newcastle disease viras), Ferlavirus (e.g., Fer-de-Lance virus), Henipavirus (e.g., hendravirus and nipahviras), Morbillivirus (e.g., measles viras, canine distemper viras, ovine rinderpest viras, phocine distemper virus, and rinderpest virus), Respirovirus (e.g., human parainfluenza viruses 1 and 3, and Sendai viras), Rubulavirus (e.g., mumps viras, human parainfluenza viruses 2 and 4, Menangle viras, simian parainfluenza virus 5, Tioman viras, and Tuhokoviruses 1 , 2 and 3), TPMV-like viruses (e.g., Mossman virus, Nariva viras, Salem virus, and Tupaia paramyxovirus), Beilong viras, Pneumovirus (e.g., human respiratory syncytial virus and bovine respiratory syncytial viras), Metapneumovirus (e.g., human metapneumoviras and avian pneumovirus), J virus, Sunshine viras, and Tailam virus]; picomaviruses [including Aphthovirus (e.g., foot-and-mouth disease virus, bovine rhinitis A virus, bovine rhinitis B virus, and equine rhinitis A virus), Avihepatovirus (e.g., duck hepatitis A virus), Cardiovirus (e.g., encephalomyocarditis virus and Theilovirus), Enterovirus (e.g., human enteroviruses A to D, simian enterovirus A, bovine enterovirus, porcine enterovirus B, and human rhinoviruses A to C), Erbovirus (e.g., equine rhinitis B virus), Hepatovirus (e.g., hepatitis A virus), Kobuvirus (e.g., Aichi virus and bovine kobuvirus), Parechovirus (e.g., human parechovirus and Ljungan virus), Salivirus (e.g., Salivirus A), Sapelovirus (e.g., avian sapelovirus, porcine sapelovirus, and simian sapelovirus), Senecavirus (e.g., Seneca Valley virus), Teschovirus (e.g., porcine teschovirus), and Tremovirus (e.g., avian encephalomyelitis virus)]; retroviruses [including Alpharetrovirus (e.g., avian leukosis virus and rous sarcoma virus), Betaretrovirus (e.g., mouse mammary tumour virus), Gammaretrovirus (e.g., murine leukemia virus and feline leukemia virus), Deltaretrovirus (e.g., human T-lymphotropic virus and bovine leukemia virus), Epsilonretrovirus (e.g., Walleye dermal sarcoma virus), Lentivirus (e.g., human

immunodeficiency viruses (HIV), simian immunodeficiency viruses, and feline immunodeficiency viruses), and Spumavirus (e.g., simian foamy virus)]; rhabdoviruses [including Cytorhabdovirus (e.g., lettuce necrotic yellows virus), Dichorhabdovirus (e.g., orchid fleck virus), Ephemerovirus (e.g., bovine ephemeral fever virus), Lyssavirus (e.g., rabies virus), Novirhabdovirus (e.g., infectious hematopoietic necrosis virus), Nudeorhabdovirus (e.g., potato yellow dwarf virus), and Vesiculovirus (e.g., vesicular stomatitis Indiana virus)]; and togaviruses [including Rubivirus (e.g., rubella virus) and Alphavirus (e.g., Chikungunya virus, Eastern equine encephalitis virus, Western equine encephalitis virus, Venezuelan equine encephalitis virus, O'nyong'nyong virus, Ross River virus, Semliki Forest virus, and Sindbis virus)] .

[0075] In some embodiments, the composition containing the biological material further comprises one or more substances selected from the group consisting of reducing agents, antioxidants, free radical scavengers, oxygen radical scavengers, hydroxyl radical scavengers, singlet oxygen quenchers, hydroperoxide-removing agents, protease inhibitors, nuclease inhibitors, ribonuclease (RNase) inhibitors, deoxyribonuclease (DNase) inhibitors, metal chelators, preservatives, antimicrobials, buffers (or buffering agents), detergents, and chaotropes. The composition can comprise the one or more substances in appropriate amounts to enhance, e.g., the stability and/or the solubility of the biological material in the substantially water-free fluid medium. It is understood that a substance can have one or more functions or properties. As an example, a substance can be a reducing agent, an antioxidant, a free radical scavenger, an oxygen radical scavenger, a hydroxyl radical scavenger or a singlet oxygen quencher, or any combination thereof. As another example, a substance can be a metal chelator, a DNase inhibitor or an anti-microbial, or any combination thereof.

[0076] Examples of reducing agents, antioxidants, and free radical scavengers include without limitation cysteine, dithionite, dithioerythritol, dithiothreitol (DTT), dysteine, 2-mercaptoethanol, mercaptoethylene, bisulfite, sodium metabisulfite, pyrosulfite, pentaerythritol, thioglycolic acid, urea, uric acid, vitamin C, vitamin E, superoxide dismutases, and analogs, derivatives and salts thereof.

[0077] Non-limiting examples of oxygen radical scavengers include sugar alcohols (e.g., erythritol, mannitol, sorbitol, and xylitol), monosaccharides (e.g., hexoses, allose, altrose, fructose, fucose, fuculose, galactose, glucose, gulose, idose, mannose, rhamnose, sorbose, tagatose, talose, pentoses, arabinose, lyxose, ribose, deoxyribose, ribulose, xylose, xylulose, tetroses, erythrose, erythrulose, and threose), disaccharides (e.g., cellobiose, lactose, maltose, sucrose, and trehalose), complex sugars (e.g., trisaccharides, kestose, isomaltotriose, maltotriose, maltotriulose, melezitose, nigerotriose, raffinose, tetrasaccharides, stachyose, fructo-polysaccharides, galacto-polysaccharides, mannan-polysaccharides, gluco-polysaccharides, glycogen, starch, amylose, amylopectin, dextrin, cellulose, glucans, beta-glucans, dextran, fructans, inulin, glucosamine polysaccharides, chitin, aminoglycosides, apramycin, gentamycin, kanamycin, netilmicin, neomycin, paromomycin, streptomycin, tobramycin, glycosaminoglycans (mucopolysaccharides), chondroitin sulfate, dermatan sulfate, keratan sulfate, heparin, heparan sulfate, and hyaluronan), and analogs, derivatives and salts thereof.

[0078] Examples of hydroxyl radical scavengers include without limitation azides (e.g., sodium azide), cysteine, dimethylsulfoxide, histidine, salicylic acid, salicylate, sugar alcohols (e.g., erythritol, mannitol, sorbitol, and xylitol), monosaccharides (e.g., those described herein), disaccharides (e.g., cellobiose, lactose, maltose, sucrose, and trehalose), complex sugars (e.g., those described herein), and analogs, derivatives and salts thereof.

[0079] Non-limiting examples of singlet oxygen quenchers include azides (e.g., sodium azide), ascorbic acid, ascorbate, alkyl imidazoles (e.g., carnosine, histamine, histidine, and imidazole 4-acetic acid), indoles (e.g., tryptophan and derivatives thereof, such as N-acetyl -5-methoxytryptamine, N- acetyl serotonin, and 6-methoxy-l,2,3,4-tetrahydro-beta-carboline), sulfur-containing amino acids (e.g., cysteine, S-allyl-cysteine, S-aminoethyl-cysteine, djenkolic acid, ethionine, methionine, N- formyl-methionine, lanthionine, and felinine), phenolic compounds (e.g., tyrosine and derivatives thereof), aromatic carboxylic acids (e.g., salicylic acid and derivatives thereof), vitamin A and derivatives thereof (e.g., carotenoids, beta-carotene, retinol and retinal), vitamin E and derivatives thereof (e.g., tocopherols, alpha-tocopherol and tocotrienols), and analogs, derivatives and salts thereof.

[0080] Examples of hydroperoxide-removing agents include without limitation catalase, glutathione, peroxidases, glutathione peroxidases, pyruvate, and analogs, derivatives and salts thereof.

[0081] Non-limiting examples of protease inhibitors include aspartic protease inhibitors, cysteine protease inhibitors, metalloprotease inhibitors, serine protease inhibitors, threonine protease inhibitors, trypsin inhibitors (e.g., avian egg white trypsin inhibitors, bovine trypsin inhibitors, lima bean trypsin inhibitors, and soybean trypsin inhibitors such as Kunitz trypsin inhibitor and Bowman- Birk inhibitor), Kunitz-type protease inhibitors, 4-(2-aminoethyl)benzenesulfonyl fluoride (AEBSF) and salts thereof (e.g., HC1 salt), amastatin, antithrombin III, antipain, APMSF, aprotinin, bestatin, benzamidine, calpain inhibitors I and II, chymostatin, 3,4-dichloroisocoumarin, diisopropyl fluorophosphate (DFP), E-64, elastatinal, hirustasin, leupeptin, alpha-2-macroglobulin, Pefabloc SC, pepstatin, 1,10-phenanthroline, phosphoramidon, phenylmethylsulfonyl fluoride (PMSF), PMSF Plus, tissue inhibitors of metalloproteinases (e.g., TIMP-1, TIMP-2, TIMP-3 and TIMP-4), tosyllysine chloromethyl ketone (TLCK) and salts thereof (e.g., HC1 salt), tosyl phenylalanyl chloromethyl ketone (TPCK), and analogs, derivatives and salts thereof.

[0082] Non-limiting examples of RNase inhibitors include mammalian ribonuclease inhibitor proteins [e.g., porcine ribonuclease inhibitor and human ribonuclease inhibitor (e.g., human placenta ribonuclease inhibitor and recombinant human ribonuclease inhibitor)], aurintricarboxylic acid (ATA) and salts thereof [e.g., triammonium aurintricarboxylate (aluminon)], adenosine 5 '-pyrophosphate, 2'- cytidine monophosphate free acid (2'-CMP), 5'-diphosphoadenosine 3'-phosphate (ppA-3'-p), 5'- diphosphoadenosine 2'-phosphate (ppA-2'-p), leucine, oligovinysulfonic acid, poly(aspartic acid), tyrosine-glutamic acid polymer, 5'-phospho-2'-deoxyuridine 3 '-pyrophosphate P'→5 '-ester with adenosine 3 '-phosphate (pdUppAp), and analogs, derivatives and salts thereof.

[0083] Examples of DNase inhibitors and metal chelators include without limitation

aurintricarboxylic acid (ATA) and salts thereof [e.g., triammonium aurintricarboxylate (aluminon)], boric acid, borate, citric acid, citrate, salicylic acid, salicylate, l,2-bis(o-aminophenoxy)ethane- Ν,Ν,Ν',Ν'-tetraacetic acid (BAPTA), diethylene triamine pentaacetic acid (DTPA),

ethylenediaminetetraacetic acid (EDTA), ethylene glycol tetraacetic acid (EGTA),

glycoletherdiaminetetraacetic acid (GEDTA), N-(2-hydroxyethyl)ethylenediamine-N,N',N'-triacetic acid (HEDTA), nitrilotriacetic acid (NTA), 2,2'-bipyridine, o-phenanthroline, triethanolamine, and analogs, derivatives and salts thereof.

[0084] Examples of preservatives include without limitation azides (e.g., sodium azide), polyethylene glycol (PEG), and anti-microbials (e.g., anti-biotic, anti-fungal, anti-parasitic and antiviral agents). Anti-microbials include without limitation beta-lactams, penicillins, semi-synthetic penicillins, mono-bactams, carboxypenems, aminoglycosides, glycopeptides, lincomycins, macrolides, allylamines, azoles, polyenes, tetraenes, sulfonamides, pyrimidines, thiocarbamates, benzoic acid compounds, rifamycins, tetracyclines, reverse transcriptase inhibitors, protease inhibitors, thymidine kinase inhibitors, glycoprotein synthesis inhibitors, sugar synthesis inhibitors, glucan synthesis inhibitors, structural protein synthesis inhibitors, viral maturation inhibitors, nucleoside analogs, polypeptides, and analogs, derivatives and salts thereof. For example, antimicrobials include without limitation penicillin, cephalosporin, ampicillin, amoxycillin, aztreonam, clavulanic acid, imipenem, streptomycin, gentamycin, vancomycin, clindamycin, polymyxin, erythromycin, bacitracin, amphotericin, nystatin, rifampicin, tetracycline, chlortetracycline, doxycycline, chloramphenicol, ammolfme, butenafine, naftifine, terbinafme, ketoconazole, fluconazole, elubiol, econazole, econaxole, itraconazole, isoconazole, imidazole, miconazole, sulconazole, clotrimazole, enilconazole, oxiconazole, tioconazole, terconazole, butoconazole, thiabendazole, voriconazole, saperconazole, sertaconazole, fenticonazole, posaconazole, bifonazole, flutrimazole, nystatin, pimaricin, amphotericin B, flucytosine, natamycin, tolnaftate, mafenide, dapsone, caspofungin, actofunicone, griseofulvin, potassium iodide, Gentian Violet, ciclopirox, ciclopirox olamine, haloprogin, silver sulfadiazine, undecylenate, undecylenic acid, undecylenic alkanolamide, Carbol-Fuchsin, nevirapine, delavirdine, efavirenz, saquinavir, ritonavir, indinavir, nelfinavir, amprenavir, zidovudine (AZT), stavudine (d4T), larnivudine (3TC), didanosine (DDI), zalcitabine (ddC), abacavir, acyclovir, penciclovir, valacyclovir, ganciclovir, and analogs, derivatives and salts thereof.

[0085] In some embodiments, the buffers or buffering agents provide buffering in a basic pH range (e.g., about pH 7 or 8 to 11, about pH 7 or 8 to 10, about pH 7 or 8 to 9, about pH 10-11, about pH 9-10, about pH 8-9, or about pH 7-8). Non-limiting examples of buffers or buffering agents that provide buffering in a basic pH range include borate, saline phosphate, saline sodium citrate, 2- (methylamino)succinic acid, N,N-bis(2-hydroxyethyl)glycine (bicine), N- tris(hydroxymethyl)methylglycine (tricine), tris(hydroxymethyl)methylamine (Tris), 2- (cyclohexylamino)ethanesulfonic acid (CHES), 4-(2-hydroxyethyl)-l -piperazineethanesulfonic acid (HEPES), piperazine-N,N'-bis(2-ethanesulfonic acid) (PIPES), 2-

{[tris(hydroxymethyl)methyl] amino } ethanesulfonic acid (TES), 3-amino-l -propanesulfonic acid, 3- (cyclohexylamino)-l-propanesulfonic acid (CAPS), 3-(cyclohexylamino)-2-hydroxy-l- propanesulfonic acid (CAPSO), N-(2-hydroxyethyl)piperazine-N'-(3-propanesulfonic acid) (EPPS), 3- (N-morpholino)propanesulfonic acid (MOPS), 3- {[tris(hydroxymethyl)methyl]amino} - propanesulfonic acid (TAPS), 3-[N-tris(hydroxymethyl)methylamino]-2-hydroxypropanesulfonic acid (TAPSO), 4-(cyclohexylamino)-l -butanesulfonic acid (CABS), and analogs, derivatives and salts thereof.

[0086] The detergents can be denaturing detergents or non-denaturing detergents. Non-limiting examples of denaturing detergents and non-denaturing detergents include anionic surfactants, cationic surfactants, non-ionic surfactants, zwitterionic surfactants, ampholytic surfactants, benzethonium chloride, cetyltrimethylammonium bromide (CTAB),3-[(3-cholamidopropyl)dimethylammonio]-l - propanesulfonate (CHAPS), 3-[(3-cholamidopropyl)dimethylammonio]-2-hydroxy-l- propanesulfonate (CHAPSO), N,N-dimethyl-decylamine-N-oxide, guanidinium thiocyanate, hexadecyltrimethylammonium bromide, lithium dodecyl sulfate (LDS), sodium dodecyl sulfate (SDS), sodium lauryl sulfate, sodium cholate, sodium deoxycholate, ethoxylated fatty alcohol ethers, lauryl ethers, ethoxylated alkyl phenol compounds [e.g., ethoxylated nonyl phenol compounds, such as NP-40 (nonyl phenoxypolyethoxylethanol)], octylphenoxy polyethoxy ethanol compounds, modified oxyethylated straight-chain alcohols, modified oxypropylated straight-chain alcohols, polyethylene glycol mono-oleate compounds, polysorbate compounds (e.g., polyoxyethylene sorbitan monolaurate compounds, such as Polysorbates (T weens) 20, 40, 60 and 80), phenolic fatty alcohol ethers, phenolic polyethylene glycols (e.g., Triton X-100), and analogs, derivatives and salts thereof.

[0087] Examples of chaotropes include without limitation formamide, guanidine and salts thereof (e.g., guanidinium hydrochloride), isothiocyanate, urea, and analogs, derivatives and salts thereof.

[0088] In some embodiments, the composition containing the biological material comprises an oxygen radical scavenger. In certain embodiments, the concentration of the oxygen radical scavenger by mass (mg) relative to the volume (μΐ.) of the at least one alcohol solvent (or the at least one ionic organic solvent in other embodiments of a composition comprising a biological material in a substantially water- free fluid medium, as described below) is at least about 1%, 5%, 10%, 25%, 50%, 75%, 100%, 125%, 150%, 200%, 250% or 300%. In some embodiments, the concentration of the oxygen radical scavenger by mass (mg) relative to the volume (μΐ.) of the at least one alcohol solvent (or the at least one ionic organic solvent in other embodiments) is about 25%-150%, 25%-125%, 25%- 100%, 25%-75% or 25%-50%.

[0089] In some embodiments, the composition comprises the biological material and an oxygen radical scavenger in ethylene glycol, 1,3 -propanediol, glycerol or 1 ,2-butanediol, or any combination thereof. In certain embodiments, the oxygen radical scavenger is mannitol, mannose, sucrose or trehalose or sorbitol.

[0090] In further embodiments, the composition containing the biological material comprises one or more substances that enhance the stability of single-stranded and double-stranded polynucleotides containing RNA nucleotides and/or DNA nucleotides. In certain embodiments, the composition comprises: (a) a metal chelator, a hydroxyl radical scavenger, and an RNase inhibitor; or (b) a hydroxyl radical scavenger and a DNase inhibitor.

[0091] In additional embodiments, the composition containing the biological material comprises a metal salt, optionally in addition to one or more other substances described herein. The metal salt can enhance the stability and/or the solubility of the biological material in the substantially water-free fluid medium. As an example, the metal salt can increase the melting temperature of a double- stranded polynucleotide containing RNA nucleotides and/or DNA nucleotides. As another example, the metal salt can increase the solubility and the refolding yield, and can promote retention of the activity, of a protein (e.g., an enzyme) preserved in the substantially water-free fluid medium. In some embodiments, the metal salt comprises an M⁺¹ (or monovalent) salt or an M⁺² (or divalent) salt, or both. M⁺¹ (or monovalent) salts include without limitation lithium salts, sodium salts and potassium salts of fluoride, chloride, bromide, iodide, acetate, formate, nitrate, perchlorate (ClO f), phosphate, sulfate, tetrafluoroborate (BF₄ ^~) and thiocyanate (^~SCN), and M⁺² (or divalent) salts include magnesium salts, manganese salts and calcium salts of fluoride, chloride, bromide, iodide, acetate, formate, nitrate, perchlorate, phosphate, sulfate, tetrafluoroborate and thiocyanate. In some embodiments, the metal salt comprises LiCl, NaCl, KC1, MgCl₂ or MnCl₂, or any combination thereof.

[0092] The biological material is soluble in the substantially water- free alcohol solvent, and thus may not need to be re-dissolved for use in fluid-phase reactions or assays, including nucleic acid amplification reactions based on PCR and analytical and diagnostic assays, such as immunoassays. In some embodiments, at least about 50%, 60%, 70%, 80%, 90%, 95% or 99% of the biological material by mass is dissolved in the substantially water-free alcohol solvent, e.g., after storage of the composition comprising the biological material in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 1.5 years or 2 years. In certain embodiments, at least about 80% or 90% of the biological material by mass is dissolved in the substantially water- free alcohol solvent after storage of the composition comprising the biological material in a closed container (e.g., a capped tube, vial or well) at ambient temperature for at least about 3 months or 6 months.

[0093] Furthermore, the biological material is stable (e.g., retains its structural integrity) in the substantially water- free alcohol solvent at ambient temperature or higher, and thus does not need to be refrigerated or frozen during shipping or storage. In some embodiments, the biological material is stable (e.g., retains its structural integrity) in the substantially water-free alcohol solvent after storage of the composition comprising the biological material in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 1.5 years or 2 years. In further embodiments, the biological material is resistant to irreversible hydrolytic damage, irreversible oxidative damage, and irreversible denaturation (e.g., irreversible unfolding or irreversible loss of secondary structure or tertiary structure) after storage of the composition comprising the biological material in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 1.5 years or 2 years. In certain embodiments, the biological material is resistant to irreversible hydrolytic damage, irreversible oxidative damage, and irreversible denaturation (e.g., irreversible unfolding or irreversible loss of secondary structure or tertiary structure) after storage of the composition comprising the biological material in a closed container (e.g., a capped tube, vial or well) at ambient temperature for at least about 3 months or 6 months. [0094] In addition, the biological material retains its function or activity when it is preserved in the substantially water-free alcohol solvent at ambient temperature or higher and is tested for its function or activity under appropriate conditions (e.g., in an aqueous medium). In some

embodiments, the biological material retains its function or activity after storage of the composition comprising the biological material in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 1.5 years or 2 years. In further embodiments, the biological material retains at least about 50%, 60%, 70%, 80%, 90%, 95% or 99% of its function or activity after storage of the composition comprising the biological material in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 1.5 years or 2 years. In certain embodiments, the biological material retains at least about 90% of its function or activity after storage of the composition comprising the biological material in a closed container (e.g., a capped tube, vial or well) at ambient temperature for at least about 3 months or 6 months. The function or activity of a biological material preserved in the substantially water- free alcohol solvent and tested at a particular time point can be compared to the function or activity of a positive control, e.g., the function or activity of the biological material prepared under appropriate conditions (e.g., in an aqueous medium) shortly before its use in the test protocol (e.g., test reaction or test assay).

[0095] Non-limiting examples of retention of a biological material's function or activity include: a) a polypeptide enzyme or a polynucleotide enzyme retaining its enzymatic or catalytic function or activity; b) a polypeptide retaining its ability to regulate (e.g., agonize or antagonize/inhibit) an enzyme; c) an antibody, a polypeptide aptamer or a polynucleotide aptamer retaining its binding affinity or specificity for a target antigen, ligand or analyte; d) a polypeptide ligand of an antibody retaining its ability to be recognized and bound by the antibody; e) a hormone or a cytokine retaining its biological function or activity; f) a polypeptide therapeutic retaining its pharmacological function or activity; g) a vaccine retaining its prophylactic or immune function or activity; h) a pair of forward and reverse primers retaining their ability to prime amplification of a target polydeoxyribonucleotide or a target nucleic acid (e.g., genetic) locus; i) a reverse transcription primer retaining its ability to prime reverse transcription of a target polyribonucleotide; j) a biological sample retaining its biological activity or its function as an analyte in an assay, or components in the biological sample retaining their biological activity or their function as analytes in an assay; and k) bacterial cells retaining their infectivity in an appropriate medium (e.g., an agar medium or a fluid culture), or viral particles retaining their infectivity in an appropriate medium (e.g., a natural fluid or a laboratory cell culture). Method of preserving a biological material in an anhydrous, non-ionic organic solvent

[0096] Further embodiments of the disclosure relate to a method of preserving a biological material in a substantially water-free, non-ionic organic solvent (e.g., an alcohol solvent). In some

embodiments, the method comprises: a) mixing an aqueous mixture comprising a polypeptide, a polynucleotide or a biological sample, or any combination thereof, with at least one alcohol solvent to produce an aqueous organic mixture, wherein: the polypeptide comprises an enzyme that mediates a nucleic acid reaction, a polypeptide that regulates an enzyme, an antibody, a polypeptide ligand of an antibody, a polypeptide aptamer, a protein or enzyme useful for detection, a toxin, a hormone, a cytokine, a polypeptide therapeutic or a vaccine, or a derivative thereof or any combination thereof; the polynucleotide comprises a polynucleotide used in a nucleic acid reaction, a catalytic

polynucleotide, or a polynucleotide that binds specifically to a target ligand, or a derivative thereof or any combination thereof; the biological sample comprises a biological fluid, a biological suspension, a fluid aspirate, blood, plasma, serum, lymph, cerebrospinal fluid, gastric fluid, bile, perspiration, ocular fluid, tears, oral fluid, sputum, saliva, a buccal sample, a tonsil sample, a nasal sample, mucus, a nasopharyngeal sample, semen, urine, a vaginal sample, a cervical sample, a rectal sample, a fecal sample, a wound or purulent sample, hair, a tissue, a tissue homogenate, cells, a cellular lysate, a tissue or cell biopsy, skin cells, tumor or cancer cells, a microbe, a pathogen, a bacterium, a fungus, a protozoan or a virus, or any combination thereof; and the at least one alcohol solvent is selected from the group consisting of linear and branched C₂-C₆ acyclic alcohols having one or more hydroxyl groups and C₃-C₆ cyclic alcohols having one or more hydroxyl groups and three to six ring carbon atoms, wherein the acyclic alcohols and the cyclic alcohols optionally comprise one or more halide atoms; and b) removing water from the aqueous organic mixture, e.g., by evaporation, to produce a composition comprising the polypeptide, the polynucleotide or the biological sample, or any combination thereof, and the at least one alcohol solvent, wherein the composition is in a fluid state and is substantially free of water.

[0097] In some embodiments, the at least one alcohol solvent in the composition comprises no more than about 20%, 15%, 10%, 5%, 4%, 3%, 2%, 1% or 0.5% water by mass relative to the combined mass of water and the at least one alcohol solvent after removal of water from the aqueous organic mixture, and optionally after storage of the composition in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 1.5 years or 2 years. In certain embodiments, the at least one alcohol solvent in the composition comprises no more than about 10%), 5%> or 1%> water by mass relative to the combined mass of water and the at least one alcohol solvent after removal of water from the aqueous organic mixture, and optionally after storage of the composition in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 1.5 years or 2 years. In some embodiments, the at least one alcohol solvent in the composition comprises no more than about 10%, 5% or 1% water by mass relative to the combined mass of water and the at least one alcohol solvent after removal of water from the aqueous organic mixture and after storage of the composition in a closed container (e.g., a capped tube, vial or well) at ambient temperature for at least about 3 months or 6 months.

[0098] The at least one alcohol solvent can comprise one or more of any of the alcohol solvents described herein. Furthermore, the polypeptide, the polynucleotide or the biological sample, or any combination thereof, can comprise any polypeptide, any polynucleotide or any biological sample described herein.

[0099] In certain embodiments, water is removed from the aqueous organic mixture by evaporation. In further embodiments, removing water from the aqueous organic mixture to produce the composition in a fluid state does not pass through an intermediate solid state. In some embodiments, water is removed from the aqueous organic mixture at ambient temperature or at reduced temperature but above the freezing point of the aqueous organic mixture or the at least one alcohol solvent. In further embodiments, water is removed from the aqueous organic mixture at ambient pressure (e.g., at about 1 atm) or at reduced pressure (e.g., at about 0.1 atm, 0.2 atm, 0.3 atm, 0.4 atm, or 0.5 atm or greater). In certain embodiments, water is removed from the aqueous organic mixture at ambient temperature and ambient pressure. In other embodiments, water is removed from the aqueous organic mixture at ambient temperature and reduced pressure. In yet other embodiments, water is removed from the aqueous organic mixture at reduced pressure and at reduced temperature but above the freezing point of the aqueous organic mixture or the at least one alcohol solvent. In further embodiments, water is removed from the aqueous organic mixture at a relative humidity of no more than about 60%, 50%, 40%, 30% or 20%.

[00100] The composition can be any composition comprising a biological material in a substantially water- free alcohol solvent as described herein. For example, the composition can comprise one or more substances as described herein, where the aqueous mixture, the at least one alcohol solvent or the aqueous organic mixture, or any combination thereof, can comprise the one or more substances (e.g., the one or more substances can be added to the aqueous mixture, the at least one alcohol solvent or the aqueous organic mixture, or any combination thereof). In certain embodiments, the one or more substances comprise: (a) a protease inhibitor; (b) an oxygen radical scavenger; (c) a metal chelator, a hydroxyl radical scavenger, and an RNase inhibitor; or (d) a hydroxyl radical scavenger and a DNase inhibitor. Furthermore, the composition can comprise a metal salt as described herein, where the aqueous mixture, the at least one alcohol solvent or the aqueous organic mixture, or any combination thereof, can comprise the metal salt (e.g., the metal salt can be added to the aqueous mixture, the at least one alcohol solvent or the aqueous organic mixture, or any combination thereof). [00101] The composition can be re-hydrated by addition of an aqueous solution (e.g., water or an aqueous buffer) shortly before the composition is to be used in a biochemical reaction (e.g., PCR) or an analysis (e.g., an immunoassay).

Compositions comprising a biological material in an anhydrous, ionic organic solvent

[00102] Other embodiments of the disclosure relate to compositions comprising a biological material in a substantially water- free, ionic organic solvent. In some embodiments, such a composition comprises: a) a polypeptide, a polynucleotide or a biological sample, or any combination thereof, wherein the polypeptide comprises an enzyme that mediates a nucleic acid reaction, a polypeptide that regulates an enzyme, an antibody, a polypeptide ligand of an antibody, a polypeptide aptamer, a protein or enzyme useful for detection, a toxin, a hormone, a cytokine, a polypeptide therapeutic or a vaccine, or a derivative thereof or any combination thereof; wherein the

polynucleotide comprises a polynucleotide used in a nucleic acid reaction, a catalytic polynucleotide, or a polynucleotide that binds specifically to a target ligand, or a derivative thereof or any combination thereof; and wherein the biological sample comprises a biological fluid, a biological suspension, a fluid aspirate, blood, plasma, serum, lymph, cerebrospinal fluid, gastric fluid, bile, perspiration, ocular fluid, tears, oral fluid, sputum, saliva, a buccal sample, a tonsil sample, a nasal sample, mucus, a nasopharyngeal sample, semen, urine, a vaginal sample, a cervical sample, a rectal sample, a fecal sample, a wound or purulent sample, hair, a tissue, a tissue homogenate, cells, a cellular lysate, a tissue or cell biopsy, skin cells, tumor or cancer cells, a microbe, a pathogen, a bacterium, a fungus, a protozoan or a virus, or any combination thereof; and b) at least one ionic organic solvent comprising an organic salt and an organic hydrogen bond donor; wherein the composition is in a fluid state and is substantially free of water.

[00103] In some embodiments, the at least one ionic organic solvent in the composition comprises no more than about 20%, 15%, 10%, 5%, 4%, 3%, 2%, 1% or 0.5% water by mass relative to the combined mass of water and the at least one ionic organic solvent, e.g., after storage of the composition in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 1.5 years or 2 years. In certain embodiments, the at least one ionic organic solvent in the composition comprises no more than about 10%>, 5% or 1%> water by mass relative to the combined mass of water and the at least one ionic organic solvent, e.g., after storage of the composition in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 1.5 years or 2 years. In some embodiments, the at least one ionic organic solvent in the composition comprises no more than about 10%>, 5% or 1% water by mass relative to the combined mass of water and the at least one ionic organic solvent after storage of the composition in a closed container (e.g., a capped tube, vial or well) at ambient temperature for at least about 3 months or 6 months.

[00104] In further embodiments, the at least one ionic organic solvent is substantially soluble in water - e.g., at least about 50%, 60%, 70%, 80%, 90%, 95% or 99% of the at least one ionic organic solvent by mass or volume is soluble in water. In certain embodiments, at least about 90%>, 95% or 99% of the at least one ionic organic solvent by mass or volume is soluble in water. In an

embodiment, the at least one ionic organic solvent is miscible with water. Solubility of the at least one ionic organic solvent in water promotes transfer of a biological material from an aqueous medium to the at least one ionic organic solvent.

[00105] In yet further embodiments, the at least one ionic organic solvent has a boiling point substantially greater than that of water - e.g., a boiling point at least or greater than about 125 °C, 150 °C, 175 °C, 200 °C, 250 °C or 300 °C at a pressure of about 1 atm. In certain embodiments, the at least one ionic organic solvent has a boiling point at least or greater than about 150 °C, 200 °C or 250 °C at a pressure of about 1 atm. The at least one ionic organic solvent having a boiling point greater than the boiling point of water allows for an aqueous mixture comprising a biological material to be mixed with at least one ionic organic solvent and for water to be selectively removed (e.g., by evaporation) from the resulting aqueous organic mixture without substantial loss of the at least one ionic organic solvent.

[00106] In additional embodiments, the at least one ionic organic solvent has a dynamic (or absolute) viscosity of no more than about 2000, 1500, 1000, 500, 400, 300, 200, 100, 50 or 25 centipoise (cP) or mPa- s at ambient temperature. In certain embodiments, the at least one ionic organic solvent has a dynamic (or absolute) viscosity of no more than about 1000, 500, 200, 100 or 50 cP or mPa- s at ambient temperature. A lower dynamic (or absolute) viscosity of the at least one ionic organic solvent allows for more facile handling of the composition comprising the biological material and the at least one ionic organic solvent (e.g., using a pipette or other means of transferring the composition).

[00107] In certain embodiments, the at least one ionic organic solvent is a eutectic solvent. In further embodiments, the at least one ionic organic solvent is a deep eutectic solvent.

[00108] In some embodiments, the molar ratio of the organic salt to the organic hydrogen bond donor in the at least one ionic organic solvent is from about 5: 1 to about 1 :5, or from about 4: 1 to about 1 :4, or from about 3: 1 to about 1 :3, or from about 2:1 to about 1 :2, or from about 1.5:1 to about 1 : 1.5. In certain embodiments, the molar ratio of the organic salt to the organic hydrogen bond donor in the at least one ionic organic solvent is from about 1 : 1 to about 1 :2, or is about 1 : 1, about 1 : 1.5 or about 1 :2. [00109] The organic salt of the at least one ionic organic solvent can be any organic salt capable of forming a solvent with an organic hydrogen bond donor (e.g., by heating a mixture of the organic salt and the organic hydrogen bond donor). In certain embodiments, the organic salt of the at least one ionic organic solvent comprises one or more organic salts selected from the group consisting of primary ammonium salts, secondary ammonium salts, tertiary ammonium salts, and quaternary ammonium salts. Examples of primary ammonium salts include without limitation methylammonium salts, ethylammonium salts, propylammonium salts, butylammonium salts, 2- hydroxyethylammonium salts, 2-acetylethylammonium salts, 2-chloroethylammonium salts, 2- fluoroethylammonium salts, and benzylammonium salts.

[00110] Non-limiting examples of secondary ammonium salts include dimethylammonium salts, diethylammonium salts, dipropylammonium salts, dibutylammonium salts, bis(2-hydroxyethyl)- ammonium salts, dibenzylammonium salts, ethylmethylammonium salts, (2-hydroxyethyl)methyl- ammonium salts, (2-hydroxyethyl)ethylammonium salts, (2-acetylethyl)methylammonium salts, (2- acetylethyl)ethylammonium salts, (2-chloroethyl)methylammonium salts, (2-chloroethyl)ethyl- ammonium salts, (2-fluoroethyl)methylammonium salts, (2-fluoroethyl)ethylammonium salts, benzylmethylammonium salts, benzylethylammonium salts, benzyl(2-hydroxyethyl)ammonium salts, benzyl(2-acetylethyl)ammonium salts, benzyl(2-chloroethyl)ammonium salts, and benzyl(2- fluoroethyl)ammonium salts.

[00111] Non-limiting examples of tertiary ammonium salts include trimethylammonium salts, triethylammonium salts, dimethylethylammonium salts, diethylmethylammonium salts,

(benzyl)(ethyl)methylammonium salts, (benzyl)dimethylammonium salts, (benzyl)diethylammonium salts, (2-hydroxyethyl)dimethylammonium salts, (2-hydroxyethyl)diethylammonium salts, (2- acetylethyl)dimethylammonium salts, (2-acetylethyl)diethylammonium salts, (2-chloroethyl)- dimethylammonium salts, (2-chloroethyl)diethylammonium salts, (2-fluoroethyl)dimethyl-ammonium salts, (2-fluoroethyl)diethylammonium salts, (2-hydroxyethyl)(benzyl)methylammonium salts, (2- hydroxyethyl)(benzyl)ethylammonium salts, (2-acetylethyl)(benzyl)methylammonium salts, (2- acetylethyl)(benzyl)ethylammonium salts, (2-chloroethyl)(benzyl)methylammonium salts, (2- chloroethyl)(benzyl)ethylammonium salts, (2-fluoroethyl)(benzyl)methylammonium salts, (2- fluoroethyl)(benzyl)ethylammonium salts, [bis(2-hydroxyethyl)]methylammonium salts, [bis(2- hydroxyethyl)] ethylammonium salts, and [bis(2-hydroxyethyl)]benzylammonium salts.

[00112] Examples of quaternary ammonium salts include without limitation

tetramethylammonium salts, tetraethylammonium salts, (2-hydroxyethyl)trimethylammonium

(choline) salts, (2-hydroxyethyl)triethylammonium salts, (2-acetylethyl)trimethylammonium salts, (2- acetylethyl)-triethylammonium salts, (2-chloroethyl)trimethylammonium salts, (2- chloroethyl)triethylammonium salts, (2-fluoroethyl)trimethylammonium salts, (2- fluoroethyl)triethylammonium salts, (benzyl)(dimethyl)(2-hydroxyethyl)ammonium salts, (benzyl)(dimethyl)(2-acetylethyl)ammonium salts, (benzyl)(dimethyl)(2-chloroethyl)ammonium salts, (benzyl)(dimethyl)(2-fluoroethyl)-ammonium salts, (benzyl)(diethyl)(2-hydroxyethyl)ammonium salts, (benzyl)(diethyl)(2-acetylethyl)ammonium salts, (benzyl)(diethyl)(2-chloroethyl)ammonium salts, (benzyl)(diethyl)(2-fluoroethyl)ammonium salts, [bis(2-hydroxyethyl)]dimethylammonium salts, [bis(2-hy droxy ethyl)] -diethylammonium salts, [bis(2- hydroxyethyl) ] (benzyl) (methyl) ammonium salts, [bis(2-hydroxyethyl) ] (benzyl) (ethyl) ammonium salts, (dimethyl)(ethyl)(2-hydroxyethyl)ammonium salts, (diethyl)(methyl)(2- hydroxyethyl) ammonium salts, (benzyl)trimethylammonium salts, and (benzyl)triethylammonium salts.

[00113] The anion of the organic salt can be any anion capable of interacting (e.g., complexing or hydrogen bonding) with an organic hydrogen bond donor. In some embodiments, the anion of the organic salt is a monovalent anion. In certain embodiments, the anion of the organic salt (e.g., the primary ammonium salts, the secondary ammonium salts, the tertiary ammonium salts, and the quaternary ammonium salts described herein) is fluoride, chloride, bromide, iodide, acetate, formate, nitrate, perchlorate (ClO f), phosphate, sulfate, tetrafluoroborate (BF₄ ^~), or thiocyanate (^~SCN).

[00114] In some embodiments, the organic salt comprises a quaternary ammonium salt. In certain embodiments, the organic salt comprises a (2-hydroxyethyl)trimethylammonium (choline) salt. In further embodiments, the organic salt comprises choline chloride or choline acetate.

[00115] The organic hydrogen bond donor of the at least one ionic organic solvent can be any organic hydrogen bond donor capable of forming a solvent with an organic salt, or any organic hydrogen bond donor capable of interacting (e.g., complexing or hydrogen bonding) with the anion of an organic salt. In certain embodiments, the organic hydrogen bond donor of the at least one ionic organic solvent comprises one or more organic hydrogen bond donors selected from the group consisting of urea compounds, thiourea compounds, carbamates, amides, carboxylic acids, phenolic compounds, acyclic alcohols, and cyclic alcohols.

[00116] Non-limiting examples of urea compounds and thiourea compounds include urea, N- methylurea, Ν,Ν'-dimethylurea, N,N-dimethylurea, Ν,Ν,Ν'-trimethylurea, thiourea, N- methylthiourea, N,N'-dimethylthiourea, Ν,Ν-dimethylthiourea, and Ν,Ν,Ν'-trimethylthiourea. In an embodiment, the organic hydrogen bond donor comprises urea.

[00117] Examples of carbamates include without limitation methyl carbamate, ethyl carbamate, propyl carbamate, butyl carbamate, methyl N-methylcarbamate, ethyl N-methylcarbamate, propyl N- methylcarbamate, and butyl N-methylcarbamate. Examples of amides include without limitation acetamide, propanamide, butanamide, pentanamide, benzamide, N-methylacetamide, N- methylpropanamide, N-methylbutanamide, N-methylpentanamide, and N-methylbenzamide. In an embodiment, the organic hydrogen bond donor comprises acetamide. [00118] Non-limiting examples of carboxylic acids include adipic acid, benzoic acid, citric acid, ethylenediaminetetraacetic acid, fumaric acid, maleic acid, malonic acid, oxalic acid, phenylacetic acid, phenylpropionic acid, propane- 1,2,3 -tricarboxylic acid (tricarballylic acid), succinic acid, and tartaric acid. In certain embodiments, the organic hydrogen bond donor comprises citric acid, malonic acid or oxalic acid, or any combination thereof. Examples of phenolic compounds include without limitation phenol and tyrosine.

[00119] Examples of acyclic alcohols include without limitation the linear and branched C2-C6 acyclic alcohols having one or more hydroxyl groups and optionally comprising one or more halide atoms described herein. Examples of cyclic alcohols include without limitation ascorbic acid and the C3-C6 cyclic alcohols having one or more hydroxyl groups and three to six ring carbon atoms and optionally comprising one or more halide atoms described herein. In certain embodiments, the organic hydrogen bond donor comprises ethylene glycol, 1 ,2-propanediol, 1,3-propanediol, glycerol, 1 ,2-butanediol, 1,3-butanediol, 1 ,4-butanediol, 2,3-butanediol, 1 ,2,4-butanetriol or 1,5-pentanediol, or any combination thereof. In further embodiments, the organic hydrogen bond donor comprises ethylene glycol, 1,3-propanediol, glycerol or 1,2-butanediol, or any combination thereof.

[00120] Examples of ionic organic solvents include without limitation: (1) choline chloride or ethylammonium chloride and urea; (2) choline chloride or ethylammonium chloride and acetamide; (3) choline chloride or ethylammonium chloride and citric acid; (4) choline chloride or

ethylammonium chloride and malonic acid; (5) choline chloride or ethylammonium chloride and oxalic acid; (6) choline chloride or ethylammonium chloride and ethylene glycol; (7) choline chloride or ethylammonium chloride and glycerol; and (8) choline chloride or ethylammonium chloride and 1 ,2-butanediol.

[00121] The at least one ionic organic solvent can be prepared by any method known in the art. For example, the at least one ionic organic solvent can be prepared by heating at elevated temperature (e.g., at about 50 °C, 75 °C or 100 °C or higher) a mixture comprising one or more organic salts and one or more organic hydrogen bond donors with stirring to produce a liquid (e.g., a homogeneous liquid). An organic salt having a melting point above ambient temperature, and/or an organic hydrogen bond donor having a melting point above ambient temperature, can be used to prepare the at least one ionic organic solvent.

[00122] The composition can comprise in the substantially water-free ionic organic solvent any polypeptide, any polynucleotide or any biological sample, or any combination thereof, described herein. To enhance, e.g., the stability and/or the solubility of the biological material in the substantially water- free ionic organic solvent, the composition can further comprise a metal salt, and/or one or more substances selected from the group consisting of reducing agents, antioxidants, free radical scavengers, oxygen radical scavengers, hydroxyl radical scavengers, singlet oxygen quenchers, hydroperoxide-removing agents, protease inhibitors, nuclease inhibitors, ribonuclease (RNase) inhibitors, deoxyribonuclease (DNase) inhibitors, metal chelators, preservatives, antimicrobials, buffers (or buffering agents), detergents, and chaotropes, as described herein. In certain embodiments, the composition comprises the biological material and: (a) a protease inhibitor;

(b) an oxygen radical scavenger; (c) a metal chelator, a hydroxyl radical scavenger, and an RNase inhibitor; or (d) a hydroxyl radical scavenger and a DNase inhibitor.

[00123] The biological material is soluble in the substantially water-free ionic organic solvent, and thus may not need to be re-dissolved for use in fluid-phase reactions or assays, including nucleic acid amplification reactions based on PCR and analytical and diagnostic assays, such as

immunoassays. In some embodiments, at least about 50%, 60%, 70%, 80%, 90%, 95% or 99% of the biological material by mass is dissolved in the substantially water-free ionic organic solvent, e.g., after storage of the composition comprising the biological material in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about

1 day, 3 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 1.5 years or

2 years. In certain embodiments, at least about 80%> or 90%> of the biological material by mass is dissolved in the substantially water-free ionic organic solvent after storage of the composition comprising the biological material in a closed container (e.g., a capped tube, vial or well) at ambient temperature for at least about 3 months or 6 months.

[00124] Furthermore, the biological material is stable (e.g., retains its structural integrity) in the substantially water- free ionic organic solvent at ambient temperature or higher, and thus does not need to be refrigerated or frozen during shipping or storage. In some embodiments, the biological material is stable (e.g., retains its structural integrity) in the substantially water-free ionic organic solvent after storage of the composition comprising the biological material in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 1.5 years or 2 years. In further embodiments, the biological material is resistant to irreversible hydrolytic damage, irreversible oxidative damage, and irreversible denaturation (e.g., irreversible unfolding or irreversible loss of secondary structure or tertiary structure) after storage of the composition comprising the biological material in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 1.5 years or 2 years. In certain embodiments, the biological material is resistant to irreversible hydrolytic damage, irreversible oxidative damage, and irreversible denaturation (e.g., irreversible unfolding or irreversible loss of secondary structure or tertiary structure) after storage of the composition comprising the biological material in a closed container (e.g., a capped tube, vial or well) at ambient temperature for at least about 3 months or 6 months. [00125] In addition, the biological material retains its function or activity when it is preserved in the substantially water-free ionic organic solvent at ambient temperature or higher and is tested for its function or activity under appropriate conditions (e.g., in an aqueous medium). In some

embodiments, the biological material retains its function or activity after storage of the composition comprising the biological material in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 1.5 years or 2 years. In further embodiments, the biological material retains at least about 50%, 60%, 70%, 80%, 90%, 95% or 99% of its function or activity after storage of the composition comprising the biological material in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 1.5 years or 2 years. In certain embodiments, the biological material retains at least about 90% of its function or activity after storage of the composition comprising the biological material in a closed container (e.g., a capped tube, vial or well) at ambient temperature for at least about 3 months or 6 months. The function or activity of a biological material preserved in the substantially water- free ionic organic solvent and tested at a particular time point can be compared to the function or activity of a positive control, e.g., the function or activity of the biological material prepared under appropriate conditions (e.g., in an aqueous medium) shortly before its use in the test protocol (e.g., test reaction or test assay).

Method of preserving a biological material in an anhydrous, ionic organic solvent

[00126] Additional embodiments of the disclosure relate to a method of preserving a biological material in a substantially water- free, ionic organic solvent. In some embodiments, the method comprises: a) mixing an aqueous mixture comprising a polypeptide, a polynucleotide or a biological sample, or any combination thereof, with at least one ionic organic solvent to produce an aqueous organic mixture, wherein: the polypeptide comprises an enzyme that mediates a nucleic acid reaction, a polypeptide that regulates an enzyme, an antibody, a polypeptide ligand of an antibody, a polypeptide aptamer, a protein or enzyme useful for detection, a toxin, a hormone, a cytokine, a polypeptide therapeutic or a vaccine, or a derivative thereof or any combination thereof;

the polynucleotide comprises a polynucleotide used in a nucleic acid reaction, a catalytic

polynucleotide, or a polynucleotide that binds specifically to a target ligand, or a derivative thereof or any combination thereof; the biological sample comprises a biological fluid, a biological suspension, a fluid aspirate, blood, plasma, serum, lymph, cerebrospinal fluid, gastric fluid, bile, perspiration, ocular fluid, tears, oral fluid, sputum, saliva, a buccal sample, a tonsil sample, a nasal sample, mucus, a nasopharyngeal sample, semen, urine, a vaginal sample, a cervical sample, a rectal sample, a fecal sample, a wound or purulent sample, hair, a tissue, a tissue homogenate, cells, a cellular lysate, a tissue or cell biopsy, skin cells, tumor or cancer cells, a microbe, a pathogen, a bacterium, a fungus, a protozoan or a virus, or any combination thereof; and the at least one ionic organic solvent comprises an organic salt and an organic hydrogen bond donor; and b) removing water from the aqueous organic mixture, e.g., by evaporation, to produce a composition comprising the polypeptide, the polynucleotide or the biological sample, or any combination thereof, and the at least one ionic organic solvent, wherein the composition is in a fluid state and is substantially free of water.

[00127] In some embodiments, the at least one ionic organic solvent in the composition comprises no more than about 20%, 15%, 10%, 5%, 4%, 3%, 2%, 1% or 0.5% water by mass relative to the combined mass of water and the at least one ionic organic solvent after removal of water from the aqueous organic mixture, and optionally after storage of the composition in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about

2 years. In certain embodiments, the at least one ionic organic solvent in the composition comprises no more than about 10%>, 5% or 1%> water by mass relative to the combined mass of water and the at least one ionic organic solvent after removal of water from the aqueous organic mixture, and optionally after storage of the composition in a closed container (e.g., a capped tube, vial or well) at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 1.5 years or 2 years. In some embodiments, the at least one ionic organic solvent in the composition comprises no more than about 10%), 5%> or 1%) water by mass relative to the combined mass of water and the at least one ionic organic solvent after removal of water from the aqueous organic mixture and after storage of the composition in a closed container (e.g., a capped tube, vial or well) at ambient temperature for at least about 3 months or 6 months.

[00128] The at least one ionic organic solvent can comprise any ionic organic solvent described herein. Furthermore, the polypeptide, the polynucleotide or the biological sample, or any combination thereof, can comprise any polypeptide, any polynucleotide or any biological sample described herein.

[00129] In certain embodiments, water is removed from the aqueous organic mixture by evaporation. In further embodiments, removing water from the aqueous organic mixture to produce the composition in a fluid state does not pass through an intermediate solid state. In some embodiments, water is removed from the aqueous organic mixture at ambient temperature or at reduced temperature but above the freezing point of the aqueous organic mixture or the at least one ionic organic solvent. In further embodiments, water is removed from the aqueous organic mixture at ambient pressure (e.g., at about 1 atm) or at reduced pressure (e.g., at about 0.1 atm, 0.2 atm, 0.3 atm, 0.4 atm, or 0.5 atm or greater). In certain embodiments, water is removed from the aqueous organic mixture at ambient temperature and ambient pressure. In other embodiments, water is removed from the aqueous organic mixture at ambient temperature and reduced pressure. In yet other embodiments, water is removed from the aqueous organic mixture at reduced pressure and at reduced temperature but above the freezing point of the aqueous organic mixture or the at least one ionic organic solvent. In further embodiments, water is removed from the aqueous organic mixture at a relative humidity of no more than about 60%, 50%, 40%, 30% or 20%.

[00130] The composition can be any composition comprising a biological material in a substantially water- free ionic organic solvent as described herein. For example, the composition can comprise one or more substances as described herein, where the aqueous mixture, the at least one ionic organic solvent or the aqueous organic mixture, or any combination thereof, can comprise the one or more substances (e.g., the one or more substances can be added to the aqueous mixture, the at least one ionic organic solvent or the aqueous organic mixture, or any combination thereof). In certain embodiments, the one or more substances comprise: (a) a protease inhibitor; (b) an oxygen radical scavenger; (c) a metal chelator, a hydroxyl radical scavenger, and an RNase inhibitor; or (d) a hydroxyl radical scavenger and a DNase inhibitor. Furthermore, the composition can comprise a metal salt as described herein, where the aqueous mixture, the at least one ionic organic solvent or the aqueous organic mixture, or any combination thereof, can comprise the metal salt (e.g., the metal salt can be added to the aqueous mixture, the at least one ionic organic solvent or the aqueous organic mixture, or any combination thereof).

[00131] The composition can be re-hydrated by addition of an aqueous solution (e.g., water or an aqueous buffer) shortly before the composition is to be used in a biochemical reaction (e.g., PCR) or an analysis (e.g., an immunoassay).

Containers and kits comprising biological materials in anhydrous fluid media

[00132] Further embodiments of the disclosure relate to containers and kits containing compositions comprising biological materials in substantially water-free fluid media. A container can comprise any composition comprising a biological material in a substantially water-free fluid medium described herein. The container can be any vessel suitable for holding or storing a fluid composition. In certain embodiments, the container is a tube, a vial, a well or a chamber (including a well or chamber in a cartridge). In further embodiments, the container is any vessel suitable for keeping away moisture during storage of a composition, such as a capped tube, vial, well or chamber. A capped container can have any suitable cap, such as a snap-on cap or a screw cap. In certain embodiments, the container is a screw-cap tube or a screw-cap vial. A screw-cap tube or a screw-cap vial can have a gasket for improved sealing of the screw cap to the tube or the vial.

[00133] A kit can contain one or more compositions comprising a biological material in a substantially water- free fluid medium described herein. The kit can contain one or more containers comprising one or more compositions, as described herein. For example, a kit can contain reagents for performing a biochemical reaction (e.g., a nucleic acid amplification reaction, such as PCR or RT- PCR) or an assay (e.g., an immunoassay, such as an ELISA or a sandwich immunoassay), wherein: 1) the kit can include a container containing a composition comprising all the reagents for performing the biochemical reaction or the assay; or

2) the kit can include two or more containers, where each container contains a composition comprising one or more reagents for performing the biochemical reaction or the assay as described herein, and the one or more reagents in each of the containers can be combined prior to or at the time of their use in the biochemical reaction or the assay or can be used at different times in performing the biochemical reaction or the assay as appropriate.

[00134] If an antibody used in an immunoassay is conjugated to a detection enzyme, the kit can further comprise a substrate with which the enzyme can react to produce a detectable signal (e.g., a color change in the substrate).

[00135] As an example, a kit can comprise reagents for performing PCR or RT-PCR, wherein: 1) the kit can include a container containing a composition comprising all the reagents for performing PCR or RT-PCR; or 2) the kit can include two or more containers, where each container contains a composition comprising one or more reagents for performing PCR or RT-PCR as described herein (e.g., a DNA polymerase in one container and at least one pair of forward and reverse primers in a separate container for PCR, or a reverse transcriptase and a DNA polymerase in one container and at least one reverse transcription primer and at least one pair of forward and reverse primers in a separate container for RT-PCR), and the one or more reagents in each of the containers can be combined prior to or at the time of their use in PCR or RT-PCR.

[00136] As another example, a kit can comprise reagents for performing an ELISA or a sandwich immunoassay, wherein: 1) the kit can include two or more containers, each container containing a composition comprising one or more reagents for performing the ELISA or the sandwich

immunoassay as described herein (e.g., a first antibody in one container and a second antibody in a separate container for an ELISA or a sandwich immunoassay); and 2) the one or more reagents in each of the containers can be used at different times in performing the ELISA or the sandwich immunoassay as appropriate (e.g., the second antibody can be used subsequent to use of the first antibody in the ELISA or the sandwich immunoassay).

[00137] A kit can further comprise water or an aqueous solution (e.g., an aqueous buffer) in a container (e.g., a vial, bottle or cartridge) for re-hydration of the biological material in a composition for use, e.g., in a reaction (e.g., a PCR amplification reaction) or an assay (e.g., an analytical or diagnostic assay, such as an immunoassay) which is performed in an aqueous medium. In addition, a kit can comprise a desiccant for promoting preservation of the biological material in a substantially anhydrous state. Non-limiting examples of desiccants include activated alumina, aerogel, silica gel, benzophenone, calcium chloride, calcium sulfate, cobalt chloride, copper sulfate, lithium chloride, lithium bromide, magnesium chloride, magnesium perchlorate, magnesium sulfate, potassium carbonate, sodium chlorate, sodium chloride, sodium hydroxide, sodium sulfate, sucrose, clay (e.g., bentonite clay and montmorillonite clay), and molecular sieves. Moreover, a kit can comprise instruction for storing and using a composition, and optionally instruction for using water or an aqueous solution (e.g., an aqueous buffer) to re -hydrate the biological material in a composition.

[00138] In certain aspects the disclosure provides a liquid composition comprising: (a) one or more linear or branched C2-C6 acyclic alcohols having two or more hydroxyl groups, wherein the one or more alcohols each has a boiling point greater than 125 °C; and (b) one or more proteins having biological function; wherein the composition comprises no more than about 20% water by mass relative to the combined mass of water and the alcohols, and each protein retains its function (e.g., after rehydration). In another embodiment the one or more alcohols comprise the predominant liquid in the composition, e.g., at least 60%, 70%, 80%, 90%, 95%, 98% or 99% by mass. In another embodiment at least one of the alcohols is selected from 1 ,2-ethanediol (ethylene glycol), 1 ,2- propanediol (propylene glycol), 1,3 -propanediol, 1,2,3-propanetriol (glycerol), 1 ,2-butanediol, 1,3- butanediol, 1 ,4-butanediol, 2,3-butanediol, 1,2,3-butanetriol, 1 ,2,4-butanetriol, 1 ,2-pentanediol, 1,3- pentanediol, 1 ,4-pentanediol, 1,5-pentanediol, 2,3-pentanediol, 2,4-pentanediol, 1,2,3-pentanetriol, 1 ,2,4-pentanetriol, 1,2,5-pentanetriol, 1,3,4-pentanetriol, 1,3,5-pentanetriol, 2,3,4-pentanetriol, 1,2- hexanediol, 1,3-hexanediol, 1 ,4-hexanediol, 1,5-hexanediol, 2,3-hexanediol, 2,4-hexanediol, 2,5- hexanediol, 3,4-hexanediol, di(ethylene glycol), and tri(ethylene glycol). In another embodiment the composition comprises no more than about 15%>, 10%>, 5%>, 4%>, 3%>, 2%>, 1%> or 0.5%> water by mass relative to the combined mass of water and the alcohols. In another embodiment, at least one of the alcohols has a boiling point above 150 °C, 175 °C, 200 °C or 250 °C at a pressure of about 1 atmosphere (atm). In another embodiment, the protein is an enzyme or a binding protein (e.g., an antibody). In another embodiment, the one or more proteins are a plurality of proteins. In another embodiment, a plurality of the proteins comprise a first enzyme that catalyzes reaction of a substate to a first product, and a second enzyme that catalyzes reaction of the first product to a second product. In another embodiment, a plurality of proteins comprise a first and second binding protein that each bind to the same protein or some other non-protein anayte and are configured for performing a sandwich immunoassay. In another embodiment, the composition comprises biomolecules sufficient to perform PCR when a substrate is added, sufficient to perform reverse transcriptase PCR when a substrate is added, or sufficient to perform adaptor ligation when a DNA substrate is added. In another embodiment, the composition further comprises an oxygen radical scavenger. In another embodiment, the composition further comprises an anti-oxidant.

[00139] In another aspect the disclosure provides a method comprising a) combining a liquid composition comprising one or more linear or branched C2-C6 acyclic alcohols having two or more hydroxyl groups, wherein the one or more alcohols each has a boiling point greater than 125 °C; and one or more proteins having biological function; wherein the composition comprises no more than about 20% water by mass relative to the combined mass of water and the alcohols; and b) removing water from the combination to produce a composition substantially free of water, wherein each protein retains its function (e.g., after rehydration). In another embodiment removing water comprises subjecting the combination to sub-atmospheric pressure to evaporate the water (e.g., at no more than about 0.1 atm, 0.2 atm, 0.3 atm, 0.4 atm, or 0.5 atm, or 07 atm, 0.9 atm, or 0.9 atm. In another embodiment removing water comprises subjecting the combination to a temperature at least 10°C are above room temperature. In another embodiment method further comprises storing a composition substantially free of water for at least one day, one week, one month, or one year before rehydration. In certain embodiments, the composition is stored at room temperature, e.g., between about 21°C and 25°C. In other embodiments the composition is stored below room temperature e.g., below 0°C. In another embodiment the method further comprises rehydrating the stored composition to restore function of the protein.

[00140] In another aspect this disclosure provides a method comprising: 1) providing a composition comprising comprising (a) one or more linear or branched C2-C6 acyclic alcohols having two or more hydroxyl groups, wherein the one or more alcohol each has a boiling point greater than 125 °C; and (b) one or more proteins; wherein the composition comprises no more than about 20% water by mass relative to the combined mass of water and the alcohols, and each protein retains its structural integrity, function and activity; 2) hydrating the composition with an amount of water sufficient to restore biological activity of one or more of the proteins; 3) contacting the at least one protein with a substrate or an analyte; and 4) performing a reaction on the substrate or binding the analyte with at least one of the proteins. In one embodiment the method comprises performing a reaction on a DNA substrate, wherein the action comprises PCR, rtPCR or adaptor ligation. In another embodiment, the method comprises binding an analyte in the performance of immunoassay.

Representative embodiments

[00141] The following embodiments of the disclosure are provided by way of example only:

1. A composition comprising:

wherein the polypeptide comprises an enzyme that mediates a nucleic acid reaction, a polypeptide that regulates an enzyme, an antibody, a polypeptide ligand of an antibody, a polypeptide aptamer, a protein or enzyme useful for detection, a toxin, a hormone, a cytokine, a polypeptide therapeutic or a vaccine, or a derivative thereof or any combination thereof; wherein the polynucleotide comprises a polynucleotide used in a nucleic acid reaction, a catalytic polynucleotide, or a polynucleotide that binds specifically to a target ligand, or a derivative thereof or any combination thereof; and

wherein the biological sample comprises a biological fluid, a biological suspension, a fluid aspirate, blood, plasma, serum, lymph, cerebrospinal fluid, gastric fluid, bile, perspiration, ocular fluid, tears, oral fluid, sputum, saliva, a buccal sample, a tonsil sample, a nasal sample, mucus, a nasopharyngeal sample, semen, urine, a vaginal sample, a cervical sample, a rectal sample, a fecal sample, a wound or purulent sample, hair, a tissue, a tissue homogenate, cells, a cellular lysate, a tissue or cell biopsy, skin cells, tumor or cancer cells, a microbe, a pathogen, a bacterium, a fungus, a protozoan or a virus, or any combination thereof; and

b) at least one alcohol solvent selected from the group consisting of linear and branched C2- Ce acyclic alcohols having one or more hydroxyl groups and C3-C6 cyclic alcohols having one or more hydroxyl groups and three to six ring carbon atoms, wherein the acyclic alcohols and the cyclic alcohols optionally comprise one or more halide atoms;

wherein the composition is in a fluid state and is substantially free of water.

2. The composition of embodiment 1 , wherein the at least one alcohol solvent in the

composition comprises no more than about 20%, 10%, 5% or 2% water by mass relative to the combined mass of water and the at least one alcohol solvent.

3. The composition of any one of the preceding embodiments, wherein at least about 50%, 60%>, 70%), 80%), 90%) or 95% of the at least one alcohol solvent by volume is soluble in water.

4. The composition of embodiment 3, wherein the at least one alcohol solvent is miscible with water.

5. The composition of any one of the preceding embodiments, wherein the at least one alcohol solvent has a boiling point at least or greater than about 1 10 °C, 125 °C, 150 °C, 175 °C or 200 °C at a pressure of about 1 atmosphere (atm).

6. The composition of any one of the preceding embodiments, wherein the at least one alcohol solvent has a dynamic (or absolute) viscosity of no more than about 1500, 1000, 500, 200, 100 or 50 centipoise (cP) or mPa- s at ambient temperature.

7. The composition of any one of the preceding embodiments, wherein the linear and branched C2-C6 acyclic alcohols are linear and branched C2-C5 acyclic alcohols having one hydroxyl group and optionally comprising one or more halide atoms.

8. The composition of embodiment 7, wherein the linear and branched C2-C5 acyclic alcohols having one hydroxyl group and optionally comprising one or more halide atoms are selected from the group consisting of 2-chloroethanol, 2,2-dichloroethanol, 1 -butanol, 1 -pentanol, 2-methylbutan-l -ol, 3-methylbutan-l -ol, 2,2-dimethylpropan-l -ol, 2-pentanol, 3-methylbutan-2-ol, and 3-pentanol.

9. The composition of any one of the preceding embodiments, wherein the linear and branched C2-C6 acyclic alcohols are linear and branched C2-C6 acyclic alcohols having two or three hydroxyl groups. 10. The composition of embodiment 9, wherein the linear and branched C₂-C₆ acyclic alcohols having two or three hydroxyl groups are selected from the group consisting of 1,2-ethanediol (ethylene glycol), 1 ,2-propanediol (propylene glycol), 1,3 -propanediol, 1,2,3-propanetriol (glycerol), 1 ,2-butanediol, 1,3-butanediol, 1 ,4-butanediol, 2,3-butanediol, 1,2,3-butanetriol, 1 ,2,4-butanetriol,

1 ,2-pentanediol, 1,3-pentanediol, 1 ,4-pentanediol, 1,5-pentanediol, 2,3-pentanediol, 2,4-pentanediol, 1,2,3-pentanetriol, 1 ,2,4-pentanetriol, 1,2,5-pentanetriol, 1,3,4-pentanetriol, 1,3,5-pentanetriol, 2,3,4- pentanetriol, 1 ,2-hexanediol, 1,3-hexanediol, 1 ,4-hexanediol, 1,5-hexanediol, 2,3-hexanediol, 2,4- hexanediol, 2,5-hexanediol, 3,4-hexanediol, di(ethylene glycol), and tri(ethylene glycol).

11. The composition of embodiment 10, wherein the at least one alcohol solvent comprises ethylene glycol, 1 ,2-propanediol, 1,3-propanediol, glycerol, 1 ,2-butanediol, 1,3-butanediol, 1 ,4- butanediol, 2,3-butanediol, 1 ,2,4-butanetriol or 1,5-pentanediol, or any combination thereof.

12. The composition of embodiment 11, wherein the at least one alcohol solvent comprises ethylene glycol, 1,3-propanediol, glycerol or 1,2-butanediol, or any combination thereof.

13. The composition of any one of the preceding embodiments, wherein the linear and branched C₂-C₆ acyclic alcohols are linear and branched C₂-C₅ acyclic alcohols having two or more hydroxyl groups.

14. The composition of any one of the preceding embodiments, wherein the C₃-C₆ cyclic alcohols having one or more hydroxyl groups are C₄ or C₅ cyclic alcohols having one or more hydroxyl groups.

15. The composition of embodiment 14, wherein the at least one alcohol solvent comprises cyclobutanol or cyclopentanol, or both.

16. The composition of any one of the preceding embodiments, wherein the at least one alcohol solvent comprises two or more alcohol solvents.

17. The composition of embodiment 16, wherein the at least one alcohol solvent comprises two or more alcohol solvents selected from the group consisting of ethylene glycol, 1 ,2-propanediol, 1,3- propanediol, glycerol, 1,2-butanediol, 1,3-butanediol, 1,4-butanediol, 2,3-butanediol, 1,2,4- butanetriol, and 1,5-pentanediol.

18. The composition of embodiment 17, wherein the at least one alcohol solvent comprises: a) ethylene glycol and 1,3-propanediol; or

b) ethylene glycol and glycerol; or

c) ethylene glycol and 1 ,2-butanediol; or

d) glycerol and 1,3-propanediol; or

e) glycerol and 1,2-butanediol.

19. The composition of any one of the preceding embodiments, which comprises an enzyme that mediates a nucleic acid reaction. 20. The composition of embodiment 19, wherein the enzyme that mediates a nucleic acid reaction comprises a topoisomerase, a helicase, a DNA polymerase, a reverse transcriptase, an RNA polymerase, a DNA ligase, an RNA ligase, a DNA repair enzyme, an RNA repair enzyme, an endonuclease, an exonuclease, a deoxyribonuclease (DNase), a ribonuclease (RNase), a transposase, a restriction enzyme or a nicking enzyme, or any combination thereof.

21. The composition of embodiment 20, wherein the enzyme that mediates a nucleic acid reaction comprises a DNA polymerase, a reverse transcriptase or an RNA polymerase, or any combination thereof.

22. The composition of embodiment 21, wherein the enzyme that mediates a nucleic acid reaction comprises a DNA polymerase (e.g., a thermostable DNA polymerase, such as a Taq polymerase) used in polymerase chain reaction (PCR) or a reverse transcriptase used in PCR, or both.

23. The composition of any one of the preceding embodiments, which comprises a polynucleotide used in a nucleic acid reaction.

24. The composition of embodiment 23, wherein the polynucleotide comprises at least one primer used in PCR or reverse transcription.

25. The composition of embodiment 24, wherein the at least one primer used in PCR or reverse transcription comprises at least one pair of a forward primer and a reverse primer for amplifying at least one nucleic acid (e.g., genetic) locus, or at least one reverse transcription primer for reverse transcribing at least one polyribonucleotide, or both; and

wherein the at least one pair of forward primer and reverse primer optionally is labeled with a dye (e.g., a fluorescent dye) or the at least one reverse transcription primer optionally is labeled with a dye (e.g., a fluorescent dye), or both.

26. The composition of embodiment 25, wherein the at least one primer used in PCR comprises at least 5 or 10 different pairs of forward and reverse primers for amplifying at least 5 or 10 different short tandem repeat (STR) loci utilized in a forensic database (e.g., CODIS), and

wherein each of the at least 5 or 10 different pairs of forward and reverse primers optionally is labeled with a dye (e.g., a fluorescent dye).

27. The composition of embodiment 26, wherein the at least one primer used in PCR comprises 16 different pairs of forward and reverse primers for amplifying all 13 CODIS STR loci, Penta D, Penta E and amelogenin, and

wherein each of the 16 different pairs of forward and reverse primers optionally is labeled with a dye (e.g., a fluorescent dye).

28. The composition of any one of the preceding embodiments, which comprises one or more reagents for performing PCR, wherein: the reagents for performing PCR comprise a DNA polymerase and at least one pair of a forward primer and a reverse primer for amplifying at least one nucleic acid (e.g., genetic) locus; and the at least one pair of forward primer and reverse primer optionally is labeled with a dye (e.g., a fluorescent dye).

29. The composition of embodiment 28, wherein the at least one pair of forward and reverse primers comprises at least 5 or 10 different pairs of forward and reverse primers for amplifying at least 5 or 10 different STR loci utilized in a forensic database (e.g., CODIS), and

30. The composition of embodiment 29, wherein the at least one pair of forward and reverse primers comprises 16 different pairs of forward and reverse primers for amplifying all 13 CODIS STR loci, Penta D, Penta E and amelogenin, and

31. The composition of any one of embodiments 28 to 30, wherein the DNA polymerase comprises a thermostable DNA polymerase (e.g., a Taq polymerase).

32. The composition of any one of embodiments 28 to 31, wherein the reagents for performing PCR further comprise deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

33. The composition of embodiment 32, which comprises the DNA polymerase, the at least one pair of forward and reverse primers, deoxyribonucleotide triphosphates, and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

34. The composition of embodiment 32, which comprises the DNA polymerase and no primer.

35. The composition of embodiment 34, which further comprises deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

36. The composition of embodiment 32, which comprises the at least one pair of forward and reverse primers and no DNA polymerase.

37. The composition of embodiment 36, which further comprises deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

38. The composition of embodiment 36 or 37, which is provided in a kit comprising the composition of embodiment 34 or 35. 39. The composition of any one of embodiments 1 to 27, which comprises one or more reagents for performing reverse transcription, wherein:

the reagents for performing reverse transcription comprise a reverse transcriptase and at least one reverse transcription primer for reverse transcribing at least one polyribonucleotide; and

the at least one reverse transcription primer optionally is labeled with a dye (e.g., a fluorescent dye).

40. The composition of embodiment 39, wherein the reagents for performing reverse transcription further comprise deoxynbonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

41. The composition of embodiment 40, which comprises the reverse transcriptase, the at least one reverse transcription primer, deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

42. The composition of embodiment 40, which comprises the reverse transcriptase and no reverse transcription primer.

43. The composition of embodiment 42, which further comprises deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

44. The composition of embodiment 40, which comprises the at least one reverse transcription primer and no reverse transcriptase.

45. The composition of embodiment 44, which further comprises deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

46. The composition of embodiment 44 or 45, which is provided in a kit comprising the composition of embodiment 42 or 43.

47. The composition of any one of embodiments 1 to 27, which comprises one or more reagents for performing reverse transcription PCR (RT-PCR), wherein:

the reagents for performing RT-PCR comprise a reverse transcriptase, a DNA polymerase, at least one reverse transcription primer for reverse transcribing at least one polyribonucleotide to produce at least one polydeoxyribonucleotide complementary to the at least one polyribonucleotide, and at least one pair of a forward primer and a reverse primer for amplifying the at least one complementary polydeoxyribonucleotide; and

the at least one reverse transcription primer optionally is labeled with a dye (e.g., a fluorescent dye) and the at least one pair of forward primer and reverse primer optionally is labeled with a dye (e.g., a fluorescent dye).

48. The composition of embodiment 47, wherein the DNA polymerase comprises a thermostable DNA polymerase (e.g., a Tag polymerase). 49. The composition of embodiment 47 or 48, wherein the reagents for performing RT-PCR further comprise deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

50. The composition of embodiment 49, which comprises the reverse transcriptase, the DNA polymerase, the at least one reverse transcription primer, the at least one pair of forward and reverse primers, deoxyribonucleotide triphosphates, and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

51. The composition of embodiment 49, which comprises the reverse transcriptase, the DNA polymerase, no reverse transcription primer, and no pair of forward and reverse primers.

52. The composition of embodiment 51, which further comprises deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

53. The composition of embodiment 49, which comprises the at least one reverse transcription primer, the at least one pair of forward and reverse primers, no reverse transcriptase, and no DNA polymerase.

54. The composition of embodiment 53, which further comprises deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

55. The composition of embodiment 53 or 54, which is provided in a kit comprising the composition of embodiment 51 or 52.

56. The composition of any one of embodiments 1 to 21, which comprises reagents for performing transcription, wherein the reagents for performing transcription comprise an RNA polymerase.

57. The composition of embodiment 56, wherein the reagents for performing transcription further comprise ribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

58. The composition of any one of embodiments 1 to 18, which comprises an antibody.

59. The composition of embodiment 58, wherein the antibody is used in an immunoassay.

60. The composition of embodiment 59, wherein the immunoassay is an enzyme-linked immunosorbent assay (ELISA) or a sandwich immunoassay.

61. The composition of embodiment 59 or 60, wherein the antibody used in an immunoassay comprises an unlinked antibody, an antibody bound to a solid substrate (e.g., a bead), an antibody conjugated to a detection protein or enzyme or a fragment thereof, or any combination thereof, and wherein the antibody may or may not be labeled with a dye (e.g., a fluorescent dye, a

chemiluminescent dye, or a phosphorescent dye). 62. The composition of any one of embodiments 1 to 18, which comprises one or more reagents for performing an immunoassay, wherein:

the one or more reagents for performing an immunoassay comprise an antibody that is specific for a target antigen or analyte;

the antibody is labeled with a dye (e.g., a fluorescent dye, a chemiluminescent dye, or a phosphorescent dye) or is conjugated to a detection protein or enzyme or a fragment thereof; and the antibody optionally is bound to a solid substrate (e.g., a bead).

63. The composition of any one of embodiments 1 to 18, which comprises one or more reagents for performing a sandwich immunoassay, wherein:

the reagents for performing a sandwich immunoassay comprise a first antibody that is specific for a target antigen or analyte and a second antibody that is specific for the target antigen or analyte; the second antibody is labeled with a dye (e.g., a fluorescent dye, a chemiluminescent dye, or a phosphorescent dye) or is conjugated to a detection protein or enzyme or a fragment thereof; and the first antibody optionally is bound to a solid substrate (e.g., a bead).

64. The composition of embodiment 63, which comprises the first antibody and the second antibody.

65. The composition of embodiment 63, which comprises the first antibody and not the second antibody.

66. The composition of embodiment 63, which comprises the second antibody and not the first antibody.

67. The composition of embodiment 66, which is provided in a kit comprising the composition of embodiment 65.

68. The composition of any one of embodiments 1 to 18, which comprises one or more reagents for performing an enzyme-linked immunosorbent assay (ELISA), wherein the reagents for performing ELISA comprise:

a detection antibody that is specific for a target antigen or analyte and is conjugated to a detection enzyme or a fragment thereof; or

a first antibody that is specific for a target antigen or analyte, and a second antibody that is specific for the first antibody and is conjugated to a detection enzyme or a fragment thereof.

69. The composition of embodiment 68, which comprises the detection antibody.

70. The composition of embodiment 68, which comprises the first antibody and the second antibody.

71. The composition of embodiment 68, which comprises the first antibody and not the second antibody. 72. The composition of embodiment 68, which comprises the second antibody and not the first antibody.

73. The composition of embodiment 72, which is provided in a kit comprising the composition of embodiment 71.

74. The composition of any one of embodiments 61 to 73, wherein the detection protein or enzyme or a fragment thereof conjugated to an antibody is selected from the group consisting of: a) phycobiliproteins, phycoerythrins, B-phycoerythrin, R-phycoerythrin, and fragments and conjugates thereof;

b) streptavidin, avidin, deglycosylated avidin, and fragments and conjugates thereof;

c) peroxidases, horseradish peroxidase, and fragments and conjugates thereof; and d) phosphatases, alkaline phosphatase, and fragments and conjugates thereof.

75. The composition of any one of embodiments 1 to 18 and 58 to 74, which comprises a protein or enzyme useful for detection.

76. The composition of embodiment 75, wherein the protein or enzyme useful for detection is selected from the group consisting of:

a) phycobiliproteins, phycoerythrins, B-phycoerythrin, R-phycoerythrin, and conjugates thereof (e.g., phycoerythrin-streptavidin conjugates, phycoerythrin-alkaline phosphatase conjugates, and phycoerythrin-antibody conjugates);

b) streptavidin, avidin, deglycosylated avidin, and conjugates thereof (e.g., streptavidin-horse radish peroxidase conjugates and streptavidin-antibody conjugates);

c) peroxidases, horseradish peroxidase, and conjugates thereof (e.g., horseradish peroxidase- antibody conjugates); and

d) phosphatases, alkaline phosphatase, and conjugates thereof (e.g., alkaline phosphatase- antibody conjugates).

77. The composition of any one of embodiments 1 to 18, which comprises a biological sample, wherein the biological sample optionally can be re-hydrated by addition of water or an aqueous buffer for analysis.

78. The composition of embodiment 77, wherein the biological sample comprises whole animal (e.g., human) blood or fractionated animal (e.g., human) blood.

79. The composition of embodiment 77, wherein the biological sample comprises whole animal (e.g., human) plasma or fractionated animal (e.g., human) plasma.

80. The composition of embodiment 77, wherein the biological sample comprises whole animal (e.g., human) serum or fractionated animal (e.g., human) serum. 81. The composition of embodiment 77, wherein the biological sample comprises animal cells, mammalian cells, human cells, plant cells, microbial cells, pathogenic cells, bacterial cells, fungal cells, protozoan cells or viral particles, or any combination thereof, or lysates or extracts thereof.

82. The composition of any one of the preceding embodiments, which further comprises one or more substances selected from the group consisting of reducing agents, antioxidants, free radical scavengers, oxygen radical scavengers, hydroxyl radical scavengers, singlet oxygen quenchers, hydroperoxide -removing agents, protease inhibitors, nuclease inhibitors, ribonuclease (RNase) inhibitors, deoxyribonuclease (DNase) inhibitors, metal chelators, preservatives, anti-microbials, buffers (or buffering agents), detergents, and chaotropes.

83. The composition of embodiment 82, wherein:

a) the reducing agents, the antioxidants, and the free radical scavengers are selected from the group consisting of cysteine, dithionite, dithioerythritol, dithiothreitol (DTT), dysteine, 2- mercaptoethanol, mercaptoethylene, bisulfite, sodium metabisulfite, pyrosulfite, pentaerythritol, thioglycolic acid, urea, uric acid, vitamin C, vitamin E, superoxide dismutases, and analogs, derivatives and salts thereof;

b) the oxygen radical scavengers are selected from the group consisting of sugar alcohols (e.g., erythritol, mannitol, sorbitol, xylitol), monosaccharides (e.g., glucose, mannose), disaccharides (e.g., sucrose, trehalose), complex sugars, and analogs, derivatives and salts thereof;

c) the hydroxyl radical scavengers are selected from the group consisting of azides, sodium azide, cysteine, dimethylsulfoxide, histidine, salicylic acid, salicylate, sugar alcohols (e.g., mannitol), monosaccharides (e.g., glucose), disaccharides (e.g., sucrose), complex sugars, and analogs, derivatives and salts thereof;

d) the singlet oxygen quenchers are selected from the group consisting of azides (e.g., sodium azide), ascorbic acid, ascorbate, alkyl imidazoles (e.g., carnosine, histamine, histidine, imidazole 4- acetic acid), indoles (e.g., tryptophan and derivatives thereof, such as N-acetyl -5-methoxytryptamine, N-acetyl serotonin, 6-methoxy-l,2,3,4-tetrahydro-beta-carboline), sulfur-containing amino acids (e.g., cysteine, S-allyl-cysteine, S-aminoethyl-cysteine, djenkolic acid, ethionine, methionine, N-formyl- methionine, lanthionine, felinine), phenolic compounds (e.g., tyrosine and derivatives thereof), aromatic carboxylic acids (e.g., salicylic acid and derivatives thereof), vitamin A and derivatives thereof (e.g., carotene), vitamin E and derivatives thereof (e.g., tocopherol), and analogs, derivatives and salts thereof;

e) the hydroperoxide-removing agents are selected from the group consisting of catalase, glutathione, peroxidases, glutathione peroxidases, pyruvate, and analogs, derivatives and salts thereof; f) the protease inhibitors are selected from the group consisting of aspartic protease inhibitors, cysteine protease inhibitors, metalloprotease inhibitors, serine protease inhibitors, threonine protease inhibitors, trypsin inhibitors (e.g., avian egg white trypsin inhibitors, bovine trypsin inhibitors, lima bean trypsin inhibitors, and soybean trypsin inhibitors such as Kunitz trypsin inhibitor and Bowman- Birk inhibitor), Kunitz-type protease inhibitors, 4-(2-aminoethyl)benzenesulfonyl fluoride (AEBSF) and salts thereof (e.g., HC1 salt), amastatin, antithrombin III, antipain, APMSF, aprotinin, bestatin, benzamidine, calpain inhibitors I and II, chymostatin, 3,4-dichloroisocoumarin, diisopropyl fluorophosphate (DFP), E-64, elastatinal, hirustasin, leupeptin, alpha-2-macroglobulin, Pefabloc SC, pepstatin, 1,10-phenanthroline, phosphoramidon, phenylmethylsulfonyl fluoride (PMSF), PMSF Plus, tissue inhibitors of metalloproteinases (e.g., TIMP-1, TIMP-2, TIMP-3 and TIMP-4), tosyllysine chloromethyl ketone (TLCK) and salts there of (e.g., HC1 salt), tosyl phenylalanyl chloromethyl ketone (TPCK), and analogs, derivatives and salts thereof;

g) the RNase inhibitors are selected from the group consisting of mammalian ribonuclease inhibitor proteins (e.g., porcine ribonuclease inhibitor and human ribonuclease inhibitor), aurintricarboxylic acid (ATA) and salts thereof (e.g., triammonium aurintricarboxylate (aluminon)), adenosine 5 '-pyrophosphate, 2'-cytidine monophosphate free acid (2'-CMP), 5'-diphosphoadenosine 3'-phosphate (ppA-3'-p), 5'-diphosphoadenosine 2'-phosphate (ppA-2'-p), leucine, oligovinysulfonic acid, poly(aspartic acid), tyrosine -glutamic acid polymer, 5'-phospho-2'-deoxyuridine ,3'- pyrophosphate P'→5'-ester with adenosine 3'-phosphate (pdUppAp), and analogs, derivatives and salts thereof;

h) the DNase inhibitors and the metal chelators are selected from the group consisting of aurintricarboxylic acid (ATA) and salts thereof (e.g., triammonium aurintricarboxylate (aluminon)), boric acid, borate, citric acid, citrate, salicylic acid, 1 ,2-bis(o-aminophenoxy)ethane-N,N,N',N'- tetraacetic acid (BAPTA), diethylene triamine pentaacetic acid (DTPA), ethylenediaminetetraacetic acid (EDTA), ethylene glycol tetraacetic acid (EGTA), glycoletherdiaminetetraacetic acid (GEDTA), N-(2-hydroxyethyl)ethylenediamine-N,N',N'-triacetic acid (HEDTA), nitrilotriacetic acid (NTA), 2,2'- bipyridine, o-phenanthroline, triethanolamine, and analogs, derivatives and salts thereof;

i) the preservatives are selected from the group consisting of azides (e.g., sodium azide), polyethylene glycol (PEG), and anti-microbials;

j) the buffers or buffering agents are selected from the group consisting of borate, saline phosphate, saline sodium citrate, 2-(methylamino)succinic acid, N,N-bis(2-hydroxyethyl)glycine (bicine), N-tris(hydroxymethyl)methylglycine (tricine), tris(hydroxymethyl)methylamine (Tris), 2- (cyclohexylamino)ethanesulfonic acid (CHES), 4-(2-hydroxyethyl)-l -piperazineethanesulfonic acid (HEPES), piperazine-N,N'-bis(2-ethanesulfonic acid) (PIPES), 2-

{[tris(hydroxymethyl)methyl] amino } ethanesulfonic acid (TES), 3-amino-l -propanesulfonic acid, 3- (cyclohexylamino)-l-propanesulfonic acid (CAPS), 3-(cyclohexylamino)-2-hydroxy-l- propanesulfonic acid (CAPSO), N-(2-hydroxyethyl)piperazine-N'-(3-propanesulfonic acid) (EPPS), 3-(N-morpholino)propanesulfonic acid (MOPS), 3-{[tris(hydroxymethyl)methyl]amino}- propanesulfonic acid (TAPS), 3-[N-tris(hydroxymethyl)methylamino]-2-hydroxypropanesulfonic acid (TAPSO), 4-(cyclohexylamino)-l -butanesulfonic acid (CABS), and analogs, derivatives and salts thereof;

k) the detergents are selected from the group consisting of anionic surfactants, cationic surfactants, non-ionic surfactants, zwitterionic surfactants, ampholytic surfactants, benzethonium chloride, cetyltrimethylammonium bromide (CTAB), 3-[(3-cholamidopropyl)dimethylammonio]-l- propanesulfonate (CHAPS), 3-[(3-cholamidopropyl)dimethylammonio]-2-hydroxy-l- propanesulfonate (CHAPSO), N,N-dimethyl-decylamine-N-oxide, guanidinium thiocyanate, hexadecyltrimethylammonium bromide, lithium dodecyl sulfate (LDS), sodium dodecyl sulfate (SDS), sodium lauryl sulfate, sodium cholate, sodium deoxycholate, ethoxylated fatty alcohol ethers, lauryl ethers, ethoxylated alkyl phenol compounds (e.g., ethoxylated nonyl phenol compounds, such as NP-40 (nonyl phenoxypolyethoxylethanol)), octylphenoxy polyethoxy ethanol compounds, modified oxyethylated straight-chain alcohols, modified oxypropylated straight-chain alcohols, polyethylene glycol mono-oleate compounds, polysorbate compounds (e.g., polyoxyethylene sorbitan monolaurate compounds, such as Polysorbates (T weens) 20, 40, 60 and 80), phenolic fatty alcohol ethers, phenolic polyethylene glycols (e.g., Triton X-100), and analogs, derivatives and salts thereof; and

1) the chaotropes are selected from the group consisting of formamide, guanidine and salts thereof (e.g., guanidinium hydrochloride), isothiocyanate, urea, and analogs, derivatives and salts thereof.

84. The composition of embodiment 82 or 83, wherein the one or more substances comprise a protease inhibitor.

85. The composition of any one of embodiments 82 to 84, wherein the one or more substances comprise an oxygen radical scavenger.

86. The composition of embodiment 85, wherein the concentration of the oxygen radical scavenger by mass (mg) relative to the volume (μΐ.) of the at least one alcohol solvent is at least about 1%, 5%, 10%, 25%, 50%, 75%, 100%, 125% or 150%.

87. The composition of embodiment 86, wherein the concentration of the oxygen radical scavenger by mass (mg) relative to the volume (μΐ.) of the at least one alcohol solvent is about 25% to about 125%), or about 25% to about 75%.

88. The composition of any one of embodiments 82 to 87, wherein the one or more substances comprise:

a) a metal chelator, a hydroxyl radical scavenger, and an RNase inhibitor; or

b) a hydroxyl radical scavenger and a DNase inhibitor.

89. The composition of any one of the preceding embodiments, which further comprises a metal salt. 90. The composition of embodiment 89, wherein the metal salt comprises an M⁺¹ salt or an M⁺² salt, or both.

91. The composition of embodiment 90, wherein M⁺¹ salts include lithium salts, sodium salts and potassium salts of fluoride, chloride, bromide, iodide, acetate, formate, nitrate, perchlorate (ClO f), phosphate, sulfate, tetrafluoroborate (BF₄ ^~) and thiocyanate (^~SCN), and M⁺² salts include magnesium salts, manganese salts and calcium salts of fluoride, chloride, bromide, iodide, acetate, formate, nitrate, perchlorate, phosphate, sulfate, tetrafluoroborate and thiocyanate.

92. The composition of any one of the preceding embodiments, which comprises:

a) ethylene glycol, 1,3-propanediol, glycerol or 1 ,2-butanediol, or any combination thereof; or b) ethylene glycol, 1,3-propanediol, glycerol or 1 ,2-butanediol, or any combination thereof, and an oxygen radical scavenger.

93. The composition of any one of the preceding embodiments, wherein the polypeptide, the polynucleotide or the biological sample, or any combination thereof, is soluble in the at least one alcohol solvent.

94. The composition of embodiment 93, wherein at least about 50%, 60%, 70%, 80%, 90% or 95% of the polypeptide, the polynucleotide or the biological sample, or any combination thereof, by mass is dissolved in the at least one alcohol solvent.

95. The composition of any one of the preceding embodiments, wherein the polypeptide, the polynucleotide or the biological sample, or any combination thereof, is stable after storage at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week,

2 weeks, 1 month, 3 months, 6 months or 1 year.

96. The composition of embodiment 95, wherein the polypeptide, the polynucleotide or the biological sample, or any combination thereof, is resistant to irreversible hydrolytic damage, irreversible oxidative damage and irreversible denaturation after storage at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 1 month,

3 months, 6 months or 1 year.

97. The composition of any one of the preceding embodiments, wherein the polypeptide, the polynucleotide or the biological sample, or any combination thereof, retain their function or activity after storage at a temperature from ambient temperature to about 40 °C for at least about 1 day,

3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months or 1 year.

98. The composition of embodiment 97, wherein the polypeptide, the polynucleotide or the biological sample, or any combination thereof, retain at least about 50%, 60%, 70%, 80%, 90% or 95%) of their function or activity after storage at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months or 1 year. 99. A method of preserving a polypeptide, a polynucleotide or a biological sample, comprising: a) mixing an aqueous mixture comprising a polypeptide, a polynucleotide or a biological sample, or any combination thereof, with at least one alcohol solvent to produce an aqueous organic mixture, wherein:

the polypeptide comprises an enzyme that mediates a nucleic acid reaction, a polypeptide that regulates an enzyme, an antibody, a polypeptide ligand of an antibody, a polypeptide aptamer, a protein or enzyme useful for detection, a toxin, a hormone, a cytokine, a polypeptide therapeutic or a vaccine, or a derivative thereof or any combination thereof;

the polynucleotide comprises a polynucleotide used in a nucleic acid reaction, a catalytic polynucleotide, or a polynucleotide that binds specifically to a target ligand, or a derivative thereof or any combination thereof;

the biological sample comprises a biological fluid, a biological suspension, a fluid aspirate, blood, plasma, serum, lymph, cerebrospinal fluid, gastric fluid, bile, perspiration, ocular fluid, tears, oral fluid, sputum, saliva, a buccal sample, a tonsil sample, a nasal sample, mucus, a nasopharyngeal sample, semen, urine, a vaginal sample, a cervical sample, a rectal sample, a fecal sample, a wound or purulent sample, hair, a tissue, a tissue homogenate, cells, a cellular lysate, a tissue or cell biopsy, skin cells, tumor or cancer cells, a microbe, a pathogen, a bacterium, a fungus, a protozoan or a virus, or any combination thereof; and

the at least one alcohol solvent is selected from the group consisting of linear and branched

C₂-C₆ acyclic alcohols having one or more hydroxyl groups and C₃-C₆ cyclic alcohols having one or more hydroxyl groups and three to six ring carbon atoms, wherein the acyclic alcohols and the cyclic alcohols optionally comprise one or more halide atoms; and

b) removing water from the aqueous organic mixture to produce a composition comprising the polypeptide, the polynucleotide or the biological sample, or any combination thereof, and the at least one alcohol solvent,

wherein the composition is in a fluid state and is substantially free of water.

100. The method of embodiment 99, wherein the at least one alcohol solvent in the composition comprises no more than about 20%, 10%, 5% or 2% water by mass relative to the combined mass of water and the at least one alcohol solvent.

101. The method of embodiment 99 or 100, wherein the at least one alcohol solvent comprises the at least one alcohol solvent of any one of embodiments 3 to 18.

102. The method of any one of embodiments 99 to 101, wherein water is removed from the aqueous organic mixture by evaporation. 103. The method of any one of embodiments 99 to 102, wherein removing water from the aqueous organic mixture is performed at ambient temperature or reduced temperature.

104. The method of any one of embodiments 99 to 103, wherein removing water from the aqueous organic mixture is performed at ambient pressure or reduced pressure.

105. The method of any one of embodiments 99 to 104, wherein removing water from the aqueous organic mixture is performed at a relative humidity of no more than about 60%, 50%, 40%>, 30%> or 20%.

106. The method of any one of embodiments 99 to 105, wherein removing water from the aqueous organic mixture to produce the composition in a fluid state does not pass through an intermediate solid state.

107. The method of any one of embodiments 99 to 106, wherein the composition is the composition of any one of embodiments 1 to 98.

108. The method of embodiment 107, wherein the composition comprises one or more substances of any one of embodiments 82 to 88, and wherein the aqueous mixture, the at least one alcohol solvent or the aqueous organic mixture, or any combination thereof, comprises the one or more substances.

109. The method of embodiment 108, wherein the one or more substances comprise:

a) a protease inhibitor;

b) an oxygen radical scavenger;

c) a metal chelator, a hydroxyl radical scavenger, and an RNase inhibitor; or

d) a hydroxyl radical scavenger and a DNase inhibitor.

110. The method of any one of embodiments 107 to 109, wherein the composition comprises a metal salt of any one of embodiments 89 to 91, and wherein the aqueous mixture, the at least one alcohol solvent or the aqueous organic mixture, or any combination thereof, comprises the metal salt.

111. The method of any one of embodiments 99 to 110, further comprising adding an aqueous solution (e.g., water or an aqueous buffer) to the composition to rehydrate the composition [e.g., shortly before the composition is to be used in a biochemical reaction (e.g., PCR) or an analysis (e.g., an immunoassay)] .

112. A composition comprising:

b) at least one ionic organic solvent comprising an organic salt and an organic hydrogen bond donor;

wherein the composition is in a fluid state and is substantially free of water.

113. The composition of embodiment 112, wherein the at least one ionic organic solvent in the composition comprises no more than about 20%, 10%, 5% or 2% water by mass relative to the combined mass of water and the at least one ionic organic solvent.

114. The composition of embodiment 112 or 113, wherein at least about 50%, 60%, 70%, 80%, 90% or 95%) of the at least one ionic organic solvent by volume is soluble in water.

115. The composition of embodiment 114, wherein the at least one ionic organic solvent is miscible with water.

116. The composition of any one of embodiments 112 to 115, wherein the at least one ionic organic solvent has a boiling point at least or greater than about 150 °C, 200 °C or 250 °C at a pressure of about 1 atm.

117. The composition of any one of embodiments 112 to 116, wherein the at least one ionic organic solvent has a dynamic (or absolute) viscosity of no more than about 2000, 1500, 1000, 500, 300, 100 or 50 centipoise (cP) or mPa-s at ambient temperature.

118. The composition of any one of embodiments 112 to 117, wherein the at least one ionic organic solvent is a eutectic solvent.

119. The composition of embodiment 118, wherein the at least one ionic organic solvent is a deep eutectic solvent.

120. The composition of any one of embodiments 112 to 119, wherein the molar ratio of the organic salt to the organic hydrogen bond donor in the at least one ionic organic solvent is from about 5: 1 to about 1 :5, or from about 3: 1 to about 1 :3, or from about 2: 1 to about 1 :2. 121. The composition of embodiment 120, wherein the molar ratio of the organic salt to the organic hydrogen bond donor in the at least one ionic organic solvent is from about 1 : 1 to about 1 :2, or is about 1 : 1, about 1 : 1.5 or about 1 :2.

122. The composition of any one of embodiments 112 to 121, wherein the organic salt of the at least one ionic organic solvent comprises one or more organic salts selected from the group consisting of primary ammonium salts, secondary ammonium salts, tertiary ammonium salts, and quaternary ammonium salts.

123. The composition of embodiment 122, wherein the primary ammonium salts include methylammonium salts, ethylammonium salts, propylammonium salts, butylammonium salts, 2- hydroxyethylammonium salts, 2-acetylethylammonium salts, 2-chloroethylammonium salts, 2- fluoroethylammonium salts, and benzylammonium salts.

124. The composition of embodiment 122 or 123, wherein the secondary ammonium salts include dimethylammonium salts, diethylammonium salts, dipropylammonium salts, dibutylammonium salts, bis(2-hydroxyethyl)ammonium salts, dibenzylammonium salts, ethylmethylammonium salts, (2- hydroxyethyl)methylammonium salts, (2-hydroxyethyl)ethylammonium salts, (2-acetylethyl)- methylammonium salts, (2-acetylethyl)ethylammonium salts, (2-chloroethyl)methylammonium salts, (2-chloroethyl)ethylammonium salts, (2-fluoroethyl)methylammonium salts, (2-fluoroethyl)ethyl- ammonium salts, benzylmethylammonium salts, benzylethylammonium salts, benzyl(2- hydroxyethyl) ammonium salts, benzyl(2-acetylethyl)ammonium salts, benzyl(2-chloroethyl)- ammonium salts, and benzyl(2-fluoroethyl)ammonium salts.

125. The composition of any one of embodiments 122 to 124, wherein the tertiary ammonium salts include trimethylammonium salts, triethylammonium salts, dimethylethylammonium salts, diethylmethylammonium salts, (benzyl)(ethyl)methylammonium salts, (benzyl)dimethylammonium salts, (benzyl)diethylammonium salts, (2-hydroxyethyl)(ethyl)methylammonium salts, (2- acetylethyl)(ethyl)methylammonium salts, (2-chloroethyl)(ethyl)methylammonium salts, (2- fluoroethyl)(ethyl)methylammonium salts, (2-hydroxyethyl)(benzyl)methylammonium salts,(2- hydroxyethyl)(benzyl)ethylammonium salts, (2-acetylethyl)(benzyl)methylammonium salts, (2- acetylethyl)(benzyl)ethylammonium salts, (2-chloroethyl)(benzyl)methylammonium salts, (2- chloroethyl)(benzyl)ethylammonium salts, (2-fluoroethyl)(benzyl)methylammonium salts, (2- fluoroethyl)(benzyl)ethylammonium salts, [bis(2-hydroxyethyl)]methylammonium salts, [bis(2- hydroxyethyl)] ethylammonium salts, and [bis(2-hydroxyethyl)]benzylammonium salts.

126. The composition of any one of embodiments 122 to 125, wherein the quaternary ammonium salts include tetramethylammonium salts, tetraethylammonium salts, (2-hydroxyethyl)trimethyl- ammonium (choline) salts, (2-hydroxyethyl)triethylammonium salts, (2-acetylethyl)trimethyl- ammonium salts, (2-acetylethyl)triethylammonium salts, (2-chloroethyl)trimethylammonium salts, (2chloroethyl)triethylammonium salts, (2-fluoroethyl)trimethylammonium salts, (2-fluoroethyl)- triethylammonium salts, (benzyl)(dimethyl)(2-hydroxyethyl)ammonium salts, (benzyl)(diethyl)(2- hydroxyethyl) ammonium salts, [bis(2-hydroxyethyl)](benzyl)(methyl)ammonium salts, [bis(2- hydroxyethyl)](benzyl)(ethyl)ammonium salts, (dimethyl)(ethyl)(2-hydroxyethyl)ammonium salts, (diethyl)(methyl)(2-hydroxyethyl)ammonium salts, (benzyl)trimethylammonium salts, and

(benzyl)triethylammonium salts.

127. The composition of any one of embodiments 122 to 126, wherein the organic salt comprises a quaternary ammonium salt.

128. The composition of embodiment 127, wherein the organic salt comprises a choline salt.

129. The composition of any one of embodiments 122 to 128, wherein the anions of the primary ammonium salts, the secondary ammonium salts, the tertiary ammonium salts and the quaternary ammonium salts are selected from the group consisting of monovalent anions, fluoride, chloride, bromide, iodide, acetate, formate, nitrate, perchlorate (ClO ), phosphate, sulfate, tetrafluoroborate (BF₄ ^"), and thiocyanate fSCN).

130. The composition of any one of embodiments 122 to 129, wherein the organic salt comprises choline chloride or choline acetate.

131. The composition of any one of embodiments 112 to 130, wherein the organic hydrogen bond donor of the at least one ionic organic solvent comprises one or more organic hydrogen bond donors selected from the group consisting of urea compounds, thiourea compounds, carbamates, amides, carboxylic acids, phenolic compounds, acyclic alcohols, and cyclic alcohols.

132. The composition of embodiment 131 , wherein the urea compounds include urea, N- methylurea, Ν,Ν'-dimethylurea, N,N-dimethylurea, Ν,Ν,Ν'-trimethylurea, thiourea, N- methylthiourea, N,N'-dimethylthiourea, Ν,Ν-dimethylthiourea, and N,N,N'-trimethylthiourea.

133. The composition of embodiment 132, wherein the organic hydrogen bond donor comprises urea.

134. The composition of any one of embodiments 131 to 133, wherein the carbamates include methyl carbamate, ethyl carbamate, propyl carbamate, butyl carbamate, methyl N-methylcarbamate, ethyl N-methylcarbamate, propyl N-methylcarbamate, and butyl N-methylcarbamate.

135. The composition of any one of embodiments 131 to 134, wherein the amides include acetamide, propanamide, butanamide, pentanamide, benzamide, N-methylacetamide, N- methylpropanamide, N-methylbutanamide, N-methylpentanamide, and N-methylbenzamide.

136. The composition of any one of embodiments 131 to 135, wherein the carboxylic acids include adipic acid, benzoic acid, citric acid, ethylenediaminetetraacetic acid, fumaric acid, maleic acid, malonic acid, oxalic acid, phenylacetic acid, phenylpropionic acid, propane- 1,2,3 -tricarboxylic acid (tricarballylic acid), succinic acid, and tartaric acid.

137. The composition of any one of embodiments 131 to 136, wherein the phenolic compounds include phenol and tyrosine.

138. The composition of any one of embodiments 131 to 137, wherein the acyclic alcohols include linear and branched C2-C6 acyclic alcohols having one or more hydroxyl groups and optionally comprising one or more halide atoms.

139. The composition of embodiment 138, wherein the linear and branched C2-C6 acyclic alcohols having one or more hydroxyl groups are selected from the group consisting of:

i) linear and branched C2-C5 acyclic alcohols having one hydroxyl group and optionally comprising one or more halide atoms; and

ii) linear and branched C2-C6 acyclic alcohols having two or more hydroxyl groups and optionally comprising one or more halide atoms.

140. The composition of embodiment 139, wherein the linear and branched C2-C5 acyclic alcohols having one hydroxyl group are selected from the group consisting of 2-chloroethanol, 2,2- dichloroethanol, 1-butanol, 1-pentanol, 2-methylbutan-l-ol, 3-methylbutanol-ol, 2,2- dimethylpropan-l-ol, 2-pentanol, 3-methylbutan-2-ol, and 3-pentanol.

141. The composition of embodiment 139, wherein the linear and branched C₂-C₆ acyclic alcohols have two or three hydroxyl groups.

142. The composition of embodiment 141, wherein the linear and branched C₂-C₆ acyclic alcohols having two or three hydroxyl groups are selected from the group consisting of 1,2-ethanediol (ethylene glycol), 1 ,2-propanediol (propylene glycol), 1,3 -propanediol, 1,2,3-propanetriol (glycerol), 1 ,2-butanediol, 1,3-butanediol, 1 ,4-butanediol, 2,3-butanediol, 1,2,3-butanetriol, 1 ,2,4-butanetriol,

143. The composition of embodiment 142, wherein the organic hydrogen bond donor comprises ethylene glycol, 1 ,2-propanediol, 1,3-propanediol, glycerol, 1 ,2-butanediol, 1,3-butanediol, 1 ,4- butanediol, 2,3-butanediol, 1 ,2,4-butanetriol or 1,5-pentanediol, or any combination thereof.

144. The composition of embodiment 143, wherein the organic hydrogen bond donor comprises ethylene glycol, 1,3-propanediol, glycerol or 1,2-butanediol, or any combination thereof. 145. The composition of any one of embodiments 139 to 144, wherein the linear and branched C₂- C₆ acyclic alcohols are linear and branched C₂-C₅ acyclic alcohols having two or more hydroxyl groups.

146. The composition of any one of embodiments 131 to 145, wherein the cyclic alcohols include C₃-C₆ cyclic alcohols having one or more hydroxyl groups and three to six ring carbon atoms and optionally comprising one or more halide atoms.

147. The composition of embodiment 146, wherein the C3-C6 cyclic alcohols having one or more hydroxyl groups are C4 or C₅ cyclic alcohols having one or more hydroxyl groups.

148. The composition of embodiment 147, wherein the C4 or C₅ cyclic alcohols are cyclobutanol, cyclopentanol or ascorbic acid, or any combination thereof.

149. The composition of any one of embodiments 131 to 148, wherein the acyclic alcohols and the cyclic alcohols have a boiling point at least or greater than about 110 °C, 125 °C, 150 °C, 175 °C or 200 °C at a pressure of about 1 atm.

150. The composition of any one of embodiments 131 to 149, wherein the acyclic alcohols and the cyclic alcohols have a dynamic (or absolute) viscosity of no more than about 1500, 1000, 500, 200, 100 or 50 cP or mPa-s at ambient temperature.

151. The composition of any one of embodiments 112 to 150, which comprises an enzyme that mediates a nucleic acid reaction.

152. The composition of embodiment 151, wherein the enzyme that mediates a nucleic acid reaction comprises a topoisomerase, a helicase, a DNA polymerase, a reverse transcriptase, an RNA polymerase, a DNA ligase, an RNA ligase, a DNA repair enzyme, an RNA repair enzyme, an endonuclease, an exonuclease, a deoxyribonuclease (DNase), a ribonuclease (RNase), a transposase, a restriction enzyme or a nicking enzyme, or any combination thereof.

153. The composition of embodiment 152, wherein the enzyme that mediates a nucleic acid reaction comprises a DNA polymerase, a reverse transcriptase or an RNA polymerase, or any combination thereof.

154. The composition of embodiment 153, wherein the enzyme that mediates a nucleic acid reaction comprises a DNA polymerase (e.g., a thermostable DNA polymerase, such as a Taq polymerase) used in polymerase chain reaction (PCR) or a reverse transcriptase used in PCR, or both.

155. The composition of any one of embodiments 112 to 154, which comprises a polynucleotide used in a nucleic acid reaction.

156. The composition of embodiment 155, wherein the polynucleotide comprises at least one primer used in PCR or reverse transcription. 157. The composition of embodiment 156, wherein the at least one primer used in PCR or reverse transcription comprises at least one pair of a forward primer and a reverse primer for amplifying at least one nucleic acid (e.g., genetic) locus, or at least one reverse transcription primer for reverse transcribing at least one polyribonucleotide, or both; and

158. The composition of embodiment 157, wherein the at least one primer used in PCR comprises at least 5 or 10 different pairs of forward and reverse primers for amplifying at least 5 or 10 different short tandem repeat (STR) loci utilized in a forensic database (e.g., CODIS), and

159. The composition of embodiment 158, wherein the at least one primer used in PCR comprises 16 different pairs of forward and reverse primers for amplifying all 13 CODIS STR loci, Penta D, Penta E and amelogenin, and

160. The composition of any one of embodiments 112 to 159, which comprises one or more reagents for performing PCR, wherein:

the reagents for performing PCR comprise a DNA polymerase and at least one pair of a forward primer and a reverse primer for amplifying at least one nucleic acid (e.g., genetic) locus; and the at least one pair of forward primer and reverse primer optionally is labeled with a dye (e.g., a fluorescent dye).

161. The composition of embodiment 160, wherein the at least one pair of forward and reverse primers comprises at least 5 or 10 different pairs of forward and reverse primers for amplifying at least 5 or 10 different STR loci utilized in a forensic database (e.g., CODIS), and

162. The composition of embodiment 161, wherein the at least one pair of forward and reverse primers comprises 16 different pairs of forward and reverse primers for amplifying all 13 CODIS STR loci, Penta D, Penta E and amelogenin, and

163. The composition of any one of embodiments 160 to 162, wherein the DNA polymerase comprises a thermostable DNA polymerase (e.g., a Ta polymerase). 164. The composition of any one of embodiments 160 to 163, wherein the reagents for performing PCR further comprise deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

165. The composition of embodiment 164, which comprises the DNA polymerase, the at least one pair of forward and reverse primers, deoxyribonucleotide triphosphates, and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

166. The composition of embodiment 164, which comprises the DNA polymerase and no primer.

167. The composition of embodiment 166, which further comprises deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

168. The composition of embodiment 164, which comprises the at least one pair of forward and reverse primers and no DNA polymerase.

169. The composition of embodiment 168, which further comprises deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

170. The composition of embodiment 168 or 169, which is provided in a kit comprising the composition of embodiment 166 or 167.

171. The composition of any one of embodiments 112 to 159, which comprises one or more reagents for performing reverse transcription, wherein:

172. The composition of embodiment 171, wherein the reagents for performing reverse transcription further comprise deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

173. The composition of embodiment 172, which comprises the reverse transcriptase, the at least one reverse transcription primer, deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

174. The composition of embodiment 172, which comprises the reverse transcriptase and no reverse transcription primer.

175. The composition of embodiment 174, which further comprises deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

176. The composition of embodiment 172, which comprises the at least one reverse transcription primer and no reverse transcriptase. 177. The composition of embodiment 176, which further comprises deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

178. The composition of embodiment 176 or 177, which is provided in a kit comprising the composition of embodiment 174 or 175.

179. The composition of any one of embodiments 112 to 159, which comprises one or more reagents for performing reverse transcription PCR (RT-PCR), wherein:

180. The composition of embodiment 179, wherein the DNA polymerase comprises a thermostable DNA polymerase (e.g., a Taq polymerase).

181. The composition of embodiment 179 or 180, wherein the reagents for performing RT-PCR further comprise deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

182. The composition of embodiment 181, which comprises the reverse transcriptase, the DNA polymerase, the at least one reverse transcription primer, the at least one pair of forward and reverse primers, deoxyribonucleotide triphosphates, and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

183. The composition of embodiment 181, which comprises the reverse transcriptase, the DNA polymerase, no reverse transcription primer, and no pair of forward and reverse primers.

184. The composition of embodiment 183, which further comprises deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

185. The composition of embodiment 181, which comprises the at least one reverse transcription primer, the at least one pair of forward and reverse primers, no reverse transcriptase, and no DNA polymerase.

186. The composition of embodiment 185, which further comprises deoxyribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride). 187. The composition of embodiment 185 or 186, which is provided in a kit comprising the composition of embodiment 183 or 184.

188. The composition of any one of embodiments 112 to 153, which comprises reagents for performing transcription, wherein the reagents for performing transcription comprise an RNA polymerase.

189. The composition of embodiment 188, wherein the reagents for performing transcription further comprise ribonucleotide triphosphates and optionally a buffer and/or a metal salt (e.g., magnesium chloride).

190. The composition of any one of embodiments 112 to 150, which comprises an antibody.

191. The composition of embodiment 190, wherein the antibody is used in an immunoassay.

192. The composition of embodiment 191, wherein the immunoassay is an enzyme-linked immunosorbent assay (ELISA) or a sandwich immunoassay.

193. The composition of embodiment 191 or 192, wherein the antibody used in an immunoassay comprises an unlinked antibody, an antibody bound to a solid substrate (e.g., a bead), an antibody conjugated to a detection protein or enzyme or a fragment thereof, or any combination thereof, and wherein the antibody may or may not be labeled with a dye (e.g., a fluorescent dye, a

chemiluminescent dye, or a phosphorescent dye).

194. The composition of any one of embodiments 112 to 150, which comprises one or more reagents for performing an immunoassay, wherein:

195. The composition of any one of embodiments 112 to 150, which comprises one or more reagents for performing a sandwich immunoassay, wherein:

196. The composition of embodiment 195, which comprises the first antibody and the second antibody. 197. The composition of embodiment 195, which comprises the first antibody and not the second antibody.

198. The composition of embodiment 195, which comprises the second antibody and not the first antibody.

199. The composition of embodiment 198, which is provided in a kit comprising the composition of embodiment 197.

200. The composition of any one of embodiments 112 to 150, which comprises one or more reagents for performing an enzyme-linked immunosorbent assay (ELISA), wherein the reagents for performing ELISA comprise:

201. The composition of embodiment 200, which comprises the detection antibody.

202. The composition of embodiment 200, which comprises the first antibody and the second antibody.

203. The composition of embodiment 200, which comprises the first antibody and not the second antibody.

204. The composition of embodiment 200, which comprises the second antibody and not the first antibody.

205. The composition of embodiment 204, which is provided in a kit comprising the composition of embodiment 203.

206. The composition of any one of embodiments 193 to 205, wherein the detection protein or enzyme or a fragment thereof conjugated to an antibody is selected from the group consisting of: a) phycobiliproteins, phycoerythrins, B-phycoerythrin, R-phycoerythrin, and fragments and conjugates thereof;

207. The composition of any one of embodiments 112 to 150 and 190 to 206, which comprises a protein or enzyme useful for detection.

208. The composition of embodiment 207, wherein the protein or enzyme useful for detection is selected from the group consisting of: a) phycobiliproteins, phycoerythrins, B-phycoerythrin, R-phycoerythrin, and conjugates thereof (e.g., phycoerythrin-streptavidin conjugates, phycoerythrin-alkaline phosphatase conjugates, and phycoerythrin-antibody conjugates);

209. The composition of any one of embodiments 112 to 150, which comprises a biological sample, wherein the biological sample optionally can be re-hydrated by addition of water or an aqueous buffer for analysis.

210. The composition of embodiment 209, wherein the biological sample comprises whole animal (e.g., human) blood or fractionated animal (e.g., human) blood.

211. The composition of embodiment 209, wherein the biological sample comprises whole animal (e.g., human) plasma or fractionated animal (e.g., human) plasma.

212. The composition of embodiment 209, wherein the biological sample comprises whole animal (e.g., human) serum or fractionated animal (e.g., human) serum.

213. The composition of embodiment 209, wherein the biological sample comprises animal cells, mammalian cells, human cells, plant cells, microbial cells, pathogenic cells, bacterial cells, fungal cells, protozoan cells or viral particles, or any combination thereof, or lysates or extracts thereof.

214. The composition of any one of embodiments 112 to 213, which further comprises one or more substances selected from the group consisting of reducing agents, antioxidants, free radical scavengers, oxygen radical scavengers, hydroxyl radical scavengers, singlet oxygen quenchers, hydroperoxide -removing agents, protease inhibitors, nuclease inhibitors, ribonuclease (RNase) inhibitors, deoxyribonuclease (DNase) inhibitors, metal chelators, preservatives, anti-microbials, buffers (or buffering agents), detergents, and chaotropes.

215. The composition of embodiment 214, wherein:

a) the reducing agents, the antioxidants, and the free radical scavengers are selected from the group consisting of cysteine, dithionite, dithioerythritol, dithiothreitol (DTT), dysteine, 2- mercaptoethanol, mercaptoethylene, bisulfite, sodium metabisulfite, pyrosulfite, pentaerythritol, thioglycolic acid, urea, uric acid, vitamin C, vitamin E, superoxide dismutases, and analogs, derivatives and salts thereof; b) the oxygen radical scavengers are selected from the group consisting of sugar alcohols (e.g., erythritol, mannitol, sorbitol, xylitol), monosaccharides (e.g., glucose, mannose), disaccharides (e.g., sucrose, trehalose), complex sugars, and analogs, derivatives and salts thereof;

d) the singlet oxygen quenchers are selected from the group consisting of azides (e.g., sodium azide), ascorbic acid, ascorbate, alkyl imidazoles (e.g., carnosine, histamine, histidine, imidazole 4- acetic acid), indoles (e.g., tryptophan and derivatives thereof, such as N-acetyl-5-methoxytryptamine, N-acetyl serotonin, 6-methoxy-l,2,3,4-tetrahydro-beta-carboline ), sulfur-containing amino acids (e.g., cysteine, S-allyl-cysteine, S-aminoethyl-cysteine, djenkolic acid, ethionine, methionine, N- formyl-methionine, lanthionine, felinine), phenolic compounds (e.g., tyrosine and derivatives thereof), aromatic carboxylic acids (e.g., salicylic acid and derivatives thereof), vitamin A and derivatives thereof (e.g., carotene), vitamin E and derivatives thereof (e.g., tocopherol), and analogs, derivatives and salts thereof;

g) the RNase inhibitors are selected from the group consisting of mammalian ribonuclease inhibitor proteins (e.g., porcine ribonuclease inhibitor and human ribonuclease inhibitor),

aurintricarboxylic acid (ATA) and salts thereof (e.g., triammonium aurintricarboxylate (aluminon)), adenosine 5 '-pyrophosphate, 2'-cytidine monophosphate free acid (2'-CMP), 5'-diphosphoadenosine 3'-phosphate (ppA-3'-p), 5'-diphosphoadenosine 2'-phosphate (ppA-2'-p), leucine, oligovinysulfonic acid, poly( aspartic acid), tyrosine -glutamic acid polymer, 5'-phospho-2'-deoxyuridine 3'- pyrophosphate P'→5'-ester with adenosine 3'-phosphate (pdUppAp), and analogs, derivatives and salts thereof;

k) the detergents are selected from the group consisting of anionic surfactants, cationic surfactants, non-ionic surfactants, zwitterionic surfactants, ampholytic surfactants, benzethonium chloride, cetyltrimethylammonium bromide (CTAB), 3-[(3-cholamidopropyl)dimethylammonio]-l- propanesulfonate (CHAPS), 3-[(3-cholamidopropyl)dimethylammonio]-2-hydroxy-l- propanesulfonate (CHAPSO), N,N-dimethyl-decylamine-N-oxide, guanidinium thiocyanate, hexadecyltrimethylammonium bromide, lithium dodecyl sulfate (LDS), sodium dodecyl sulfate (SDS), sodium lauryl sulfate, sodium cholate, sodium deoxycholate, ethoxylated fatty alcohol ethers, lauryl ethers, ethoxylated alkyl phenol compounds (e.g., ethoxylated nonyl phenol compounds, such as NP-40 (nonylphenoxypolyethoxylethanol)), octylphenoxy polyethoxy ethanol compounds, modified oxyethylated straight-chain alcohols, modified oxypropylated straight-chain alcohols, polyethylene glycol mono-oleate compounds, polysorbate compounds (e.g., polyoxyethylene sorbitan monolaurate compounds, such as Polysorbates (T weens) 20, 40, 60 and 80), phenolic fatty alcohol ethers, phenolic polyethylene glycols (e.g., Triton X-100), and analogs, derivatives and salts thereof; and 1) the chaotropes are selected from the group consisting of formamide, guanidine and salts thereof (e.g., guanidinium hydrochloride), isothiocyanate, urea, and analogs, derivatives and salts thereof.

216. The composition of embodiment 214 or 215, wherein the one or more substances comprise a protease inhibitor.

217. The composition of any one of embodiments 214 to 216, wherein the one or more substances comprise an oxygen radical scavenger.

218. The composition of embodiment 217, wherein the concentration of the oxygen radical scavenger by mass (mg) relative to the volume (μΐ.) of the at least one ionic organic solvent is at least about 1%, 5%, 10%, 25%, 50%, 75%, 100%, 125% or 150%.

219. The composition of embodiment 218, wherein the concentration of the oxygen radical scavenger by mass (mg) relative to the volume (μΐ.) of the at least one ionic organic solvent is about 25% to about 125%, or about 25% to about 75%.

220. The composition of any one of embodiments 214 to 219, wherein the one or more substances comprise:

a) a metal chelator, a hydroxyl radical scavenger, and an RNase inhibitor; or

b) a hydroxyl radical scavenger and a DNase inhibitor.

221. The composition of any one of embodiments 112 to 220, which further comprises a metal salt.

222. The composition of embodiment 221 , wherein the metal salt comprises an M⁺¹ salt or an M⁺² salt, or both.

223. The composition of embodiment 222, wherein M⁺¹ salts include lithium salts, sodium salts and potassium salts of fluoride, chloride, bromide, iodide, acetate, formate, nitrate, perchlorate (ClO ), phosphate, sulfate, tetrafluoroborate (BF₄ ^~) and thiocyanate (^~SCN), and M⁺² salts include magnesium salts, manganese salts and calcium salts of fluoride, chloride, bromide, iodide, acetate, formate, nitrate, perchlorate, phosphate, sulfate, tetrafluoroborate and thiocyanate.

224. The composition of any one of embodiments 112 to 223, wherein the polypeptide, the polynucleotide or the biological sample, or any combination thereof, is soluble in the at least one ionic organic solvent.

225. The composition of embodiment 224, wherein at least about 50%, 60%, 70%, 80%, 90% or 95% of the polypeptide, the polynucleotide or the biological sample, or any combination thereof, by mass is dissolved in the at least one ionic organic solvent.

226. The composition of any one of embodiments 112 to 225, wherein the polypeptide, the polynucleotide or the biological sample, or any combination thereof, is stable after storage at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week,

2 weeks, 1 month, 3 months, 6 months or 1 year.

227. The composition of embodiment 226, wherein the polypeptide, the polynucleotide or the biological sample, or any combination thereof, is resistant to irreversible hydrolytic damage, irreversible oxidative damage and irreversible denaturation after storage at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 1 month,

3 months, 6 months or 1 year.

228. The composition of any one of embodiments 112 to 227, wherein the polypeptide, the polynucleotide or the biological sample, or any combination thereof, retain their function or activity after storage at a temperature from ambient temperature to about 40 °C for at least about 1 day,

3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months or 1 year.

229. The composition of embodiment 228, wherein the polypeptide, the polynucleotide or the biological sample, or any combination thereof, retain at least about 50%, 60%, 70%, 80%, 90% or 95%) of their function or activity after storage at a temperature from ambient temperature to about 40 °C for at least about 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months or 1 year.

230. A method of preserving a polypeptide, a polynucleotide or a biological sample, comprising: a) mixing an aqueous mixture comprising a polypeptide, a polynucleotide or a biological sample, or any combination thereof, with at least one ionic organic solvent to produce an aqueous organic mixture, wherein:

the biological sample comprises a biological fluid, a biological suspension, a fluid aspirate, blood, plasma, serum, lymph, cerebrospinal fluid, gastric fluid, bile, perspiration, ocular fluid, tears, oral fluid, sputum, saliva, a buccal sample, a tonsil sample, a nasal sample, mucus, a nasopharyngeal sample, semen, urine, a vaginal sample, a cervical sample, a rectal sample, a fecal sample, a wound or purulent sample, hair, a tissue, a tissue homogenate, cells, a cellular lysate, a tissue or cell biopsy, skin cells, tumor or cancer cells, a microbe, a pathogen, a bacterium, a fungus, a protozoan or a virus, or any combination thereof; and the at least one ionic organic solvent comprises an organic salt and an organic hydrogen bond donor; and

b) removing water from the aqueous organic mixture to produce a composition comprising the polypeptide, the polynucleotide or the biological sample, or any combination thereof, and the at least one ionic organic solvent,

wherein the composition is in a fluid state and is substantially free of water.

231. The method of embodiment 230, wherein the at least one ionic organic solvent in the composition comprises no more than about 20%, 10%, 5% or 2% water by mass relative to the combined mass of water and the at least one ionic organic solvent.

232. The method of embodiment 230 or 231, wherein the at least one ionic organic solvent comprises the at least one ionic organic solvent of any one of embodiments 114 to 150.

233. The method of any one of embodiments 230 to 232, wherein water is removed from the aqueous organic mixture by evaporation.

234. The method of any one of embodiments 230 to 233, wherein removing water from the aqueous organic mixture is performed at ambient temperature or reduced temperature.

235. The method of any one of embodiments 230 to 234, wherein removing water from the aqueous organic mixture is performed at ambient pressure or reduced pressure.

236. The method of any one of embodiments 230 to 235, wherein removing water from the aqueous organic mixture is performed at a relative humidity of no more than about 60%, 50%, 40%, 30% or 20%.

237. The method of any one of embodiments 230 to 236, wherein removing water from the aqueous organic mixture to produce the composition in a fluid state does not pass through an intermediate solid state.

238. The method of any one of embodiments 230 to 237, wherein the composition is the composition of any one of embodiments 112 to 229.

239. The method of embodiment 238, wherein the composition comprises one or more substances of any one of embodiments 214 to 220, and wherein the aqueous mixture, the at least one ionic organic solvent or the aqueous organic mixture, or any combination thereof, comprises the one or more substances.

240. The method of embodiment 239, wherein the one or more substances comprise:

a) a protease inhibitor;

b) an oxygen radical scavenger;

c) a metal chelator, a hydroxyl radical scavenger, and an RNase inhibitor; or d) a hydroxyl radical scavenger and a DNase inhibitor.

241. The method of any one of embodiments 238 to 240, wherein the composition comprises a metal salt of any one of embodiments 221 to 223, and wherein the aqueous mixture, the at least one ionic organic solvent or the aqueous organic mixture, or any combination thereof, comprises the metal salt.

242. The method of any one of embodiments 230 to 241, further comprising adding an aqueous solution (e.g., water or an aqueous buffer) to the composition to rehydrate the composition [e.g., shortly before the composition is to be used in a biochemical reaction (e.g., PCR) or an analysis (e.g., an immunoassay)] .

243. A container comprising the composition of any one of embodiments 1 to 98 and 112 to 229.

244. The container of embodiment 243, which is a tube, a vial, a well or a chamber (including a well or chamber in a cartridge).

245. A kit comprising the composition of any one of embodiments 1 to 98 and 112 to 229.

246. The kit of embodiment 245, which comprises reagents for performing a biochemical reaction (e.g., a nucleic acid amplification reaction) or an assay (e.g., an immunoassay), wherein the kit contains:

a composition comprising the reagents for performing the biochemical reaction or the assay; or

two or more compositions comprising the reagents for performing the biochemical reaction or the assay.

247. The kit of embodiment 245 or 246, which further comprises an aqueous solution (e.g., water or an aqueous buffer) for re-hydration of the polypeptide, the polynucleotide or the biological sample, or any combination thereof, of a composition.

248. The kit of any one of embodiments 245 to 247, which further comprises a desiccant.

249. The kit of any one of embodiments 245 to 248, which further comprises instruction for storing and using a composition, and optionally instruction for using an aqueous solution (e.g., water or an aqueous buffer) to re-hydrate the polypeptide, the polynucleotide or the biological sample, or any combination thereof, of the composition.

250. A composition comprising:

a) a polypeptide, a polynucleotide or a biological sample, or any combination thereof; and b) at least one C2-C6 alcohol solvent having one or more hydroxyl groups, wherein the at least one alcohol solvent is substantially soluble in water (e.g., at least about 90% soluble in water by volume or miscible in water) and has a boiling point substantially greater than that of water (e.g., a boiling point of at least about 110 °C, 125 °C or 150 °C at a pressure of about 1 atm);

wherein the composition is in a fluid state and is substantially free of water (e.g., comprising no more than about 10%, 5% or 2% water by mass relative to the combined mass of water and the composition).

251. The composition of embodiment 250, comprising a DNA polymerase (e.g., a thermostable DNA polymerase) and deoxyribonucleotide triphosphates.

252. The composition of embodiment 251, further comprising a divalent metal salt and/or a monovalent metal salt.

253. The composition of embodiment 251 or 252, further comprising a buffer compatible with PCR.

254. The composition of any one of embodiments 251 to 253, further comprising at least one pair of forward and reverse PCR primers for amplifying at least one polydeoxyribonucleotide sequence.

255. The composition of any one of embodiments 251 to 254, further comprising a reverse transcriptase.

256. The composition of embodiment 255, further comprising at least one reverse transcription primer for reverse transcribing at least one polyribonucleotide sequence.

257. The composition of embodiment 250, comprising reagents (e.g., sufficient) for performing PCR or reverse transcription PCR on a polynucleotide analyte (e.g., DNA and/or RNA), except for at least one pair of forward and reverse PCR primers and/or at least one reverse transcription primer.

258. The composition of embodiment 250, comprising reagents (e.g., sufficient) for performing PCR or reverse transcription PCR on a polynucleotide analyte (e.g., DNA and/or RNA), including at least one pair of forward and reverse PCR primers and/or at least one reverse transcription primer.

259. The composition of embodiment 250, comprising a first antibody against a first target analyte, and optionally a second, different antibody against the first antibody, the first target analyte, or a second, different target analyte, wherein the first antibody and/or the optional second antibody can be labeled with a dye (e.g., a fluorescent dye) or can be conjugated to a detection protein or enzyme or a fragment thereof.

260. The composition of embodiment 250, comprising reagents (e.g., sufficient) for performing an immunoassay on a target analyte.

261. The composition of embodiment 260, wherein the immunoassay comprises an enzyme-linked immunosorbent assay (ELISA) or a sandwich immunoassay.

262. A method comprising: providing a composition comprising:

a) a polypeptide, a polynucleotide or a biological sample, or any combination thereof; and

b) at least one C₂-C₆ alcohol solvent having one or more hydroxyl groups, wherein the at least one alcohol solvent is substantially soluble in water (e.g., at least about 90% soluble in water by volume or miscible in water) and has a boiling point substantially greater than that of water (e.g., a boiling point of at least about 110 °C, 125 °C or 150 °C at a pressure of about 1 atm);

wherein the composition is in a fluid state and is substantially free of water (e.g., comprising no more than about 10%, 5% or 2% water by mass relative to the combined mass of water and the composition); and

rehydrating the composition with an aqueous solution (e.g., water or an aqueous buffer).

263. The method of embodiment 262, further comprising contacting the rehydrated composition with an analyte (e.g., a sample polynucleotide or an antigen of an antibody).

264. The method of embodiment 263, wherein:

the composition comprises reagents (e.g., sufficient) for performing PCR or reverse transcription PCR on a polynucleotide analyte (e.g., DNA and/or RNA), except for at least one pair of forward and reverse PCR primers and/or at least one reverse transcription primer; and

the method comprises contacting the rehydrated composition with a polynucleotide analyte (e.g., DNA and/or RNA) and with at least one pair of forward and reverse PCR primers and/or at least one reverse transcription primer.

265. The method of embodiment 263, wherein:

the composition comprises reagents (e.g., sufficient) for performing PCR or reverse transcription PCR on a polynucleotide analyte (e.g., DNA and/or RNA), including at least one pair of forward and reverse PCR primers and/or at least one reverse transcription primer; and

the method comprises contacting the rehydrated composition with a polynucleotide analyte (e.g., DNA and/or RNA).

266. The method of embodiment 263, wherein:

the composition comprises reagents (e.g., sufficient) for performing an immunoassay (e.g., an ELISA or a sandwich immunoassay) on a target analyte; and

the method comprises contacting the rehydrated composition with a target analyte.

267. A kit comprising a first container containing a composition, wherein the composition comprises:

a) a polypeptide, a polynucleotide or a biological sample, or any combination thereof; and b) at least one C₂-C₆ alcohol solvent having one or more hydroxyl groups, wherein the at least one alcohol solvent is substantially soluble in water (e.g., at least about 90% soluble in water by volume or miscible in water) and has a boiling point substantially greater than that of water (e.g., a boiling point of at least about 110 °C, 125 °C or 150 °C at a pressure of about 1 atm); and

268. The kit of embodiment 267, wherein the first container comprises:

1) reagents (e.g., sufficient) for performing PCR on a polynucleotide analyte, optionally excluding or including at least one pair of forward and reverse PCR primers;

2) reagents (e.g., sufficient) for performing reverse transcription PCR on a polynucleotide analyte, optionally excluding or including at least one pair of forward and reverse PCR primers and/or at least one reverse transcription primer; or

3) reagents (e.g., sufficient) for performing an immunoassay (e.g., an ELISA or a sandwich immunoassay) on a target analyte.

269. The kit of embodiment 268, wherein:

1) the reagents (e.g., sufficient) for performing PCR on a polynucleotide analyte comprise a DNA polymerase (e.g., a thermostable DNA polymerase) and nucleotide triphosphates (e.g., deoxyribonucleotide triphosphates), and optionally a buffer, a monovalent or divalent metal salt (e.g., magnesium chloride), and/or at least one pair of forward and reverse PCR primers;

2) the reagents (e.g., sufficient) for performing reverse transcription PCR on a polynucleotide analyte comprise a DNA polymerase (e.g., a thermostable DNA polymerase), a reverse transcriptase and nucleotide triphosphates (e.g., deoxyribonucleotide triphosphates), and optionally a buffer, a monovalent or divalent metal salt (e.g., magnesium chloride), at least one pair of forward and reverse PCR primers, and/or at least one reverse transcription primer; and

3) the reagents (e.g., sufficient) for performing an immunoassay on a target analyte comprise at least one antibody against a target analyte.

270. The kit of any one of embodiments 267 to 269, further comprising a second container containing an aqueous solution (e.g., water or an aqueous buffer) for rehydrating the composition.

271. The composition of any of embodiments 1-3 which comprises one or more reagents for performing DNA processing such as library preparation for next generation sequencing of DNA, wherein: one reagent for performing DNA processing comprises a T4 polymerase or an equivalent polymerase and the composition further comprises dNTPs to generate blunt ended DNA fragments as would be required for next generation sequencing library preparation. 272. The composition of any of embodiments 1-3 which comprises one or more reagents for performing DNA processing such as library preparation for next generation sequencing of DNA, wherein: one reagent performing DNA processing comprises a T4 polynucleotide kinase or an equivalent kinase and the composition further comprises ATP to phosphorylate blunt ended DNA.

273. The composition of any of embodiments 1-3 which comprises one or more reagents for performing DNA processing such as library preparation for next generation sequencing of DNA, wherein: one reagent performing DNA processing comprises a T4 ligase or an equivalent ligase and the composition further comprises ATP to ligate adapters onto the phosphorylated, blunt ended DNA.

274. The composition of any of embodiments 1-3 which comprises one or more reagents for performing DNA processing such as library preparation for next generation sequencing of DNA, wherein: one reagent performing DNA processing comprises a Klenow polymerase or an equivent DNA polymerase and the composition further comprises dATP to generate a poly-A tail onto the phosphorylated, blunt ended DNA.

275. The composition of any of embodiments 1-3 which comprises one or more reagents for performing DNA processing such as library preparation for next generation sequencing of DNA, wherein: one reagent performing DNA processing comprises a T4 polymerase or an equivalent polymerase to generate blunt ended DNA fragments.

276. The composition of any of embodiments 1-3 which comprises one or more reagents for performing DNA processing such as library preparation for next generation sequencing of DNA, wherein: one reagent performing DNA processing comprises a T4 polynucleotide kinase or an equivalent kinase and ATP to phosphorylate blunt ended DNA.

277. The composition of any of embodiments 1-3 which comprises one or more reagents for performing DNA processing such as library preparation for next generation sequencing of DNA, wherein: one reagent comprising a T4 ligase or an equivalent ligase and ATP to ligate adapters onto the phosphorylated, blunt ended DNA.

278. The composition of any of embodiments 1-3 which comprises one or more reagents for performing DNA processing such as library preparation for next generation sequencing of DNA, wherein: one reagent performing DNA processing comprises a Klenow polymerase or an equivalent DNA polymerase and dATP to generate a poly-A tail onto the phosphorylated, blunt ended DNA.

279. The composition of embodiment 151, wherein the enzyme that mediates a nucleic acid reaction comprises a T4 polymerase or an equivalent polymerase and the composition further comprises dNTPs to generate blunt ended DNA fragments as would be required for next generation sequencing library preparation. 280. The composition of embodiment 151, wherein the enzyme that mediates a nucleic acid reaction comprises a T4 polynucleotide kinase or an equivalent kinase and the composition further comprises ATP to phosphorylate blunt ended DNA as would be required for next generation sequencing library preparation.

281. The composition of embodiment 151, wherein the enzyme that mediates a nucleic acid reaction comprises a T4 ligase or an equivalent ligase and the composition further comprises ATP to ligate adapters onto the phosphorylated, blunt ended DNA as would be required for next generation sequencing library preparation.

282. The composition of embodiment 151, wherein the enzyme that mediates a nucleic acid reaction comprises a Klenow polymerase or an equivent DNA polymerase and the composition further comprises dATP to generate a poly-A tail onto the phosphorylated, blunt ended DNA as would be required for next generation sequencing library preparation.

283. The kit of any one of embodiments 267 to 269, further comprising containers which are embedded in an integrated microfluidic device.

Examples

[00142] The following examples are intended only to illustrate the disclosure. Other procedures, methodologies, techniques, conditions and reagents may alternatively be used as appropriate.

Example 1

Preservation of RT-PCR Reagents in Glycerol for Human 18S rRNA Analysis

[00143] An undiluted volume (about 25 μΐ.) of the Master Mix of the Ag-Path ID™ One-Step RT- PCR Kit (Life Technologies) for analysis of human 18S ribosomal RNA (rRNA) was placed in a PCR tube. The volume of Master Mix contained some amount (e.g., about 0.5-4 μL) of glycerol. Varying amounts of sucrose (0 mg, or about 1.3 mg, 2.5 mg or 5 mg) were added to the Master Mix. Water was removed from the resulting mixture by evaporation at reduced pressure (about 0.2 atm) and ambient temperature overnight to yield a fluid mixture having a volume of about 4 μL. The evaporated mixture containing the RT-PCR reagents and optionally sucrose in glycerol was stored in the PCR tube capped with a snap-on cap at ambient temperature (about 25 °C) for varying periods of time (about 0 day, 7 days or 14 days).

[00144] For analysis of human 18S rRNA, nuclease-free water and template RNA (about 10 ng of HeLa total RNA) were added to the evaporated mixture in the PCR tube to a final volume of about 25 μL. Reverse transcription PCR was performed according to the manufacturer's recommended protocol. Production of the target 18S rRNA amplicon product having about 313 base pairs (bp) was analyzed by gel electrophoresis using 2% agarose gel and UV visualization. Positive control was the Master Mix not treated with sucrose and not subjected to water removal, where the Master Mix was prepared by taking unmixed RT-PCR reagents out of a -20 °C freezer and mixing them shortly before use at all tested time points (untreated and unevaporated Master Mix), with addition of the template RNA. Negative control was untreated and unevaporated Master Mix without addition of the template RNA.

[00145] Figure 1 shows electrophoresis results when reverse transcription PCR was performed at time = 0, about 7 days or about 14 days. When RT-PCR was performed shortly after preparation of the evaporated mixture (t = 0), the target 313 bp 18S rRNA product was produced if no sucrose or about 1.3 mg, 2.5 mg or 5 mg of sucrose had been added to the RT-PCR Master Mix. When RT-PCR was performed after about 7 days of storage of the evaporated mixture at ambient temperature (t = 7 days), addition of no sucrose to the Master Mix yielded a much lower amount of the target 313 bp product compared to addition of about 1.3 mg, 2.5 mg or 5 mg of sucrose to the Master Mix. When RT-PCR was performed after about 14 days of storage of the evaporated mixture at ambient temperature (t = 14 days), addition of no sucrose or about 1.3 mg of sucrose to the Master Mix resulted in no detectable target 313 bp product, whereas addition of about 2.5 mg or 5 mg of sucrose to the Master Mix produced the target 313 bp product.

Example 2

Preservation of RT-PCR Reagents in Glycerol for Avian Flu Virus RNA Analysis

[00146] An undiluted volume (about 25 μΐ.) of the RT-PCR Master Mix of the TaqMan^® Avian Influenza Virus (AIV-M) Reagents (Life Technologies) for analysis of AIV matrix (AIV-M) RNA was placed in a well of a 96- well optical PCR plate. The volume of Master Mix contained some amount (e.g., about 0.5-4 μΐ,) of glycerol. Varying amounts of sucrose (0 mg, or about 1.3 mg or 2.5 mg) were added to the Master Mix. Water was removed from the resulting mixture by evaporation at reduced pressure (about 0.2 atm) and ambient temperature overnight to yield a fluid mixture having a volume of about 4 μΐ_^. The evaporated mixture containing the RT-PCR reagents and optionally sucrose in glycerol was stored in the well capped with a snap-on cap at ambient temperature (about 25 °C) for varying periods of time (about 0 day or 7 days). The PCR plate was kept in the dark during storage to protect a dye-labeled probe in the RT-PCR reagents from light.

[00147] For analysis of avian influenza virus matrix RNA, deionized nuclease-free water and template RNA (about 10 ng of AIV genomic RNA) were added to the evaporated mixture in the well to a final volume of about 25 μΐ_^. Reverse transcription PCR was performed according to the manufacturer's recommended protocol. Production of the target amplicon product of the matrix (M) gene of AIV was analyzed using an Applied Biosystems 7500 Fast Real-Time PCR System (Life Technologies), which generated Ct values when a fluorescent signal reached a level detectable by the real-time PCR instrument. Positive control was the Master Mix not treated with sucrose and not subjected to water removal, where the Master Mix was prepared by taking unmixed RT-PCR reagents out of a -20 °C freezer and mixing them shortly before use at all tested time points (untreated and unevaporated Master Mix), with addition of the template RNA. Negative control was untreated and unevaporated Master Mix without addition of the template RNA.

[00148] Table 1 shows results when reverse transcription PCR was performed at time = 0 or about 7 days. When RT-PCR was performed shortly after preparation of the evaporated mixture (t = 0), addition of no sucrose to the RT-PCR Master Mix yielded a slightly lower amount of the target matrix product compared to addition of about 1.3 mg or 2.5 mg of sucrose to the Master Mix. When RT-PCR was performed after about 7 days of storage of the evaporated mixture at ambient temperature (t = 7 days), addition of no sucrose to the Master Mix resulted in no detectable target matrix product, while addition of about 1.3 mg of sucrose to the Master Mix produced a lower amount of the target matrix product than addition of about 2.5 mg of sucrose to the Master Mix.

Table 1

Example 3

Preservation of PCR Reagents in Glycerol for STR-Based Human Identification

[00149] An undiluted volume (about 20 μΐ.) of the Master Mix of the PowerPlex^® 16 HS System (Promega) for human identification was placed in a PCR tube. The volume of Master Mix contained some amount (e.g., about 0.5-4 μΐ.) of glycerol. The Master Mix contained 16 different pairs of forward and reverse primers for amplifying all 13 current CODIS STR loci, as well as Penta D, Penta E and amelogenin. Each primer was labeled with a fluorescent dye, and a total of three different fluorescent dyes were used to label the 16 different pairs of forward and reverse primers. Varying amounts of sucrose (0 mg, or about 1 mg or 2 mg) were added to the Master Mix. Water was removed from the resulting mixture by evaporation at reduced pressure (about 0.2 atm) and ambient temperature overnight to yield a fluid mixture having a volume of about 4 μΐ_^. The evaporated mixture containing the PCR reagents and optionally sucrose in glycerol was stored in the PCR tube capped with a snap-on cap at ambient temperature (about 25 °C) for varying periods of time (about 0 day or 7 days). The PCR tube was kept in the dark during storage to protect the dye-labeled primers from light.

[00150] For analysis of the 13 CODIS STR loci, Penta D, Penta E and amelogenin, nuclease-free water and template DNA (about 1 ng of human genomic DNA) were added to the evaporated mixture in the PCR tube to a final volume of about 20 μΐ_^. Multiplex PCR was performed according to the manufacturer's recommended protocol. Production of the amplicon products of the 16 loci was analyzed using an Applied Biosystems 3130 Genetic Analyzer instrument (Life Technologies).

Positive control was the Master Mix not treated with sucrose and not subjected to water removal, where the Master Mix was prepared by taking unmixed PCR reagents out of a -20 °C freezer and mixing them shortly before use at all tested time points (untreated and unevaporated Master Mix), with addition of the template DNA. Negative control was untreated and unevaporated Master Mix without addition of the template DNA.

[00151] Figures 2 and 3 show electropherograms when multiplex PCR was performed at time = 0 or about 7 days, respectively. When PCR was performed shortly after preparation of the evaporated mixture (t = 0), addition of no sucrose or about 1 mg or 2 mg of sucrose to the PCR Master Mix yielded similar amounts of the amplicon products of the 16 loci (Figure 2). When PCR was performed after about 7 days of storage of the evaporated mixture at ambient temperature (t = 7 days), addition of no sucrose to the Master Mix resulted in lower amounts of the amplicon products of the 16 loci compared to addition of about 1 mg or 2 mg of sucrose to the Master Mix (Figure 3).

Example 4

Preservation of Human Serum Solids in Glycerol

[00152] An aqueous solution containing varying amounts of glycerol (0 mg, or about 2.5 mg, 5 mg, 7.5 mg or 10 mg) and an aqueous solution containing varying amounts of sucrose (0 mg, or about 5 mg, 7.5 mg or 10 mg) were added to a volume (about 50 μ¾ of human serum in natural serum fluid in a tube. The volume of human serum contained about 7.5 mg of serum solids (non- volatile components of serum). Water was removed from the resulting mixture by evaporation at reduced pressure (about 0.2 atm) and ambient temperature for about two days.

[00153] Figure 4 shows evaporated mixtures containing about 7.5 mg of human serum solids and varying amounts of glycerol and sucrose, and the approximate volume of the mixtures after evaporation of water at about 0.2 atm and ambient temperature for about two days. The five evaporated mixtures containing human serum solids and sucrose in glycerol were clear and showed no apparent flocculation or precipitation of serum solids.

Example 5

Preservation of RT-PCR Reagents in Glycerol or Glycerol/l,3-Propanediol for Human 18S rRNA Analysis

[00154] An undiluted volume (about 25 μΐ.) of the Master Mix of the Ag-Path ID™ One-Step RT- PCR Kit (Life Technologies) for analysis of human 18S nbosomal RNA (rRNA) was placed in a PCR tube. The volume of Master Mix contained some amount (e.g., about 0.5-4 μL) of glycerol. Sucrose (about 2.5 mg), and glycerol (about 1 μL) or 1,3 -propanediol (about 1 μL), were added to the Master Mix. Water was removed from the resulting mixture by evaporation at reduced pressure (about 0.2 atm) and ambient temperature overnight to yield a fluid mixture having a volume of about 8 μL. After adding mineral oil (about 1 μL), 1% Triton®-X (about 1 μL of a stock solution diluted 100-fold with distilled water) or 1% Tween®-20 (about 1 μL of a stock solution diluted 100-fold with distilled water), or no additional substance, to the fluid mixture, the mixture was subjected to reduced pressure (about 0.2 atm) at ambient temperature for about two additional hours. The evaporated mixture containing the RT-PCR reagents and sucrose, and optionally mineral oil or a detergent, in glycerol or glycerol/1, 3 -propanediol was rehydrated for immediate testing or was stored in the PCR tube capped with a snap-on cap at ambient temperature (about 25 °C) for about 7 days before rehydration and testing.

[00155] For analysis of human 18S rRNA, nuclease-free water and template RNA (about 10 ng of HeLa total RNA) were added to the evaporated mixture in the PCR tube to a final volume of about 25 μL. Reverse transcription PCR was performed according to the manufacturer's recommended protocol. Production of the target 18S rRNA amplicon product having about 313 base pairs (bp) was analyzed by gel electrophoresis using 2% agarose gel and ethidium bromide for UV visualization.

[00156] Figures 5A and 5B show electrophoresis results when reverse transcription PCR was performed at time = 0 or about 7 days after sucrose and glycerol or 1,3 -propanediol ("1,3-PD"), and optionally mineral oil or a detergent, had been added to the Master Mix. For the "No overlay" tests, no mineral oil and no detergent had been added to the Master Mix. For the "Mineral oil" tests, mineral oil, but no detergent, had been added to the Master Mix, and the mineral oil was removed before RT-PCR was conducted. For the "1% Triton-X" tests, 1% Triton®-X, but no mineral oil, had been added to the Master Mix. For the "1% Tween-20" tests, 1% Tween®-20, but no mineral oil, had been added to the Master Mix. Figures 5A and 5B show that RT-PCR generated comparable levels of the target 313 bp 18S rRNA amplicon product at time = 0 or about 7 days after sucrose and glycerol or 1,3-propanediol, and optionally mineral oil or a detergent, had been added to the

Master Mix. Example 6

Preservation of Human Immunoglobulins in High Boiling Point Alcohol Solvents

[00157] A Luminex MagPix bead-based device is used to perform immunoassays. The MagPix bead based immunassay technology is used to demonstrate preservation human immunoglobulin reagents in high boiling point alcohol solvents at the extremes of temperature.

[00158] A commercial (triplex) human immunoglobulin immunoassay capable of quantifying human immunoglobulins IgA, IgGl, IgM in parallel is used, in the Luminex MagPix bead format. For those studies, a highly purified immunoglobulin standard cocktail is employed, comprising purified human [IgA, IgGl, IgM] at a fixed ratio.

[00159] For these studies, 5uL (5mg) of any particular high boiling point alcohol solvent or solvent mixture is added to 50uL of that standardized immunoglobulin (Ig) cocktail. Water is then removed by desiccation at Room Temperature at 0.1 Atm. to produce an essentially water- free @5uL high boiling point alcohol solution of the immunoglbulins. The sample is then sealed in a screw capped tube and either stored at 25C for a total of 5hrs, or 3hrs at 25C followed by a 2hr long "heat spike" at either 37C or 56C. For analysis, the sample is re-hydrated by addition of 50uL of water, mixed by pipetting, then subjected to a series of dilutions, prior to addition of anti-Ig antibody-coated magnetic beads, standard solution phase binding analysis and finally, analysis via bead imaging on the Luminex MagPix device.

[00160] Fig 6 shows that three high boiling point alcohol solvents have been screened: [glycerol]; [glycerol : 1,2PD]; [1,2 PD alone] where 1,2 PD = 1,2 propane diol. To those high boiling point alcohol solvents, is added an equal mass ratio of sucrose (5mg) alone, or in some cases an additional 1 mg or 2mgs of HPBCD (Hydroxypropyl beta-cyclodextrin) which has been described in the literature as an antioxidant and stabilizer of immunoglobulins in water solution.

[00161] Fig 6a describes the effect of 5hrs of dry, storage at 25C in several high boiling point alcohol solvents. Upon rehydration, a number of solvent treatment formulations display Ig analyte concentrations which are within 20% of the always frozen control Ig standards (green arrow). In general, those high boiling point alcohol combinations which show the lowest apparent recovery of Ig analytes are those which lack sucrose or HPBCD as antioxidant stabilizers added to the high boiling point alcohol solvents.

[00162] The effect is more striking when observed subsequent to a 2hr long 56C "heat spike", Fig 6c. Relative to the already frozen control (green arrow) only the 100% glycerol containing high boiling point alcohol solvent displays measurable retention of Ig analyte concentration. All of the observed 100%> glycerol-containing solvents have produced apparent concentrations which are equal or greater to that of the always frozen control (green arrow [00163] The data in Fig 6 show that the three principle components of nearly all immunoassays [IgA, IgG, IgM] can be preserved in high boiling point alcohol solvents, with all free water evaporated way, even upon heat treatment to 56C for 2hrs.

Example 7

Preservation of Human Serum in High Boiling Point Alcohol Solvents

[00164] This example shows the preservation of human serum in high boiling point (poly) alcohol solvents at ambient temperature upon removal of water.

[00165] Serum concentration during desiccation is minimized by adding a volume of high boiling point alcohol solvent which is identical to the volume of the serum to be preserved. The result of this is that, subsequent to water removal by evaporation at ambient temperature, serum analyte concentration in the resulting water-free high boiling point alcohol solvent or solvent pair is the same as that of the original serum starting material.

[00166] When attempting to concentrate the serum during drying into the high boiling point alcohol solvent (i.e. by adding less than one volume equivalent of the solvent) the already- concentrated serum sample displays significant aggregation upon desiccation. However, when the final serum concentration upon drying in the high boiling point alcohol solvent is equal to that of the original sample, little-to-no aggregation of flocculation can be detected and the water free, fluid serum sample rehydrates easily via simple pipetting.

[00167] Preliminary experiments show that [100% Glycerol] is too viscous as a high boiling point alcohol solvent for preservation of whole serum, and so three low- viscosity, high boiling point alcohol solvent alternatives provide for better serum fluidics in the water free state: [ethylene glycol];

[glycerol +1,3 propanediol at 1-1 by mass] and pure 1,3 propanedoil. I OOUL of freshly thawed human serum is used in each instance. To that is added 1 OOuL of the solvent or solvent pair of interest plus any added antioxidant stabilizer. The stabilizer additive tested in Example 7 and displayed in Fig 7 has been (Hydroxypropyl beta-cyclodextrin) which to save space has been abbreviated as "CD" in Fig 7.

[00168] The resulting samples are then dried at 25C at 0.1 Atm for 2.5hrs, thus removing all free water as assessed by the final volume. Subsequent to storage at lab ambient temperature, the specimen is then rehydrated by addition of water, pipet mixing and immediate analysis via the human triplex [IgA, IgGl, IgM] Luminex MagPix Immunoassay decribed in Example 6. In all instances, a matched never-dried, freshly thawed serum sample is analyzed in parallel on the Luminex MagPix device.

[00169] As seen in Fig 7, the data demonstrate nearly quantitative recovery of serum

immunoglobulin activity in all three [IgA, IgGl, IgM] relative to the matched untreated serum sample (green arrow). From these data (Fig 7) it would seem that all three high boiling point alcohol solvents provide for equivalent preservation of immunoglobulins IgA, IgGl, IgM in human serum.

Example 8

Preservation Human Influenza rtPCR Reagents in Glycerol and Propane Diol

[00170] An rtPCR kit is implemented to analyze humanized influenza A, based on the sequence data of Spackman et al. (Example 8, Table A)

[00171] Example 8, Table A. Influenza q-rtPCR Test Developed

[00172] Several solvents are tested to preserve rtPCR function. Here is demonstrated the use of a 1-1 mixture of glycerol (G) and 1,3 propanediol "G:PD" in this Example: chosen because the 1-1 blend is both stabilizing and presents upon dehydration, a fluid with viscosity low enough for routine pipetting of the desiccated product.

[00173] The design of these experiments: Enough kit reagent is placed in a PCR tube to support a complete q-rtPCR reaction (lacking only the influenza RNA template). [Omg, lmg, 2mg, 3mg] of the G:PD solvent pair and a free radical quencher (sucrose) at [Omg, 0.8mg or 2.5mg] is then added to the aqueous q-rtPCR reaction and the resulting aqueous solution is dried under vacuum (0.1 atm) at room temperature overnight. The resulting water-free fluid phase is then rehydrated by addition of water, 1 Ong of RNA template added and the q-rtPCR reaction is performed to yield the real time assay parameter (Ct). As a control an identical (standard) q-rtPCR reaction control is performed without addition of high boiling point alcohol solvent or desiccation, which is found to yield a standard Ct value of (20.4 +/- 0.3). Example 8, Table B. Stabilization of a q-rtPCR Reaction Kit for Human Influenza:

Data Obtained Dry, Immediately after Overnight Vacuum Dehydration.

Example 8, Table C. Stabilization of a q-rtPCR Reaction Kit for Human Influenza:

Data Obtained after Overnight Drying then & 12 Days of Dry State RT Storage.

[00174] Conclusions. The data in Example 8, Table B demonstrate that immediately after vacuum drying, all 1 : 1 [Glycerol: 1,3PD] formulations with sucrose display measured Ct values in the 20-21 range, very close to the control value (20.4 +/- 0.3) obtained for the matched, never-dried q-rtPCR reaction, executed under standard conditions.

[00175] This important result demonstrates that the entire q-rtPCR reaction complement (reverse transcriptase, Taq polymerase, XTP, Mg+2, PCR Primers) can be desiccated into high boiling point alcohol solvent pair 1 : 1 [Glycerol: 1 ,3 PD] , without evidence of irreversible damage to any of the AIV q-rtPCR components, as assessed by full retention of function.

[00176] Subsequent to the same desiccation then 12Days of storage at room temperature (@25C), data of Example 8, Table C reveal little-to-no additional change in the activity of the influenza q- rtPCR kit relative to that seen dry at time zero, with the exception of the untreated, dried master mix (italic) which, as expected, has begun to incur storage -related decrease in activity when dried to a solid in the absence of a high boiling point alcohol solvent pair 1 : 1 [Glycerol: 1 ,3 PD] . [00177] In summary, the data of Example 8 show that the [Glycerol: 1,3PD] solvent pair [G:PD] alone or with sucrose added as an antioxidant and stabilizer preserves q-rtPCR reaction components upon desiccation to a substantially water free fluid state.

Example 9

Preservation of PCR Reagents in Glycerol plus Sucrose or Sorbitol for STR-Based Human

Identification

[00178] An undiluted volume (about 20 μΐ.) of the Master Mix of the PowerPlex^® 16 HS System (Promega) for human identification was placed in a PCR tube. The volume of Master Mix contained some amount (e.g., about 0.5-4 mg) of glycerol to which an additional O. lmg of glycerol was added . To that was added an additional 0.5mg of sorbitol or sucrose. The Master Mix contained 16 different pairs of forward and reverse primers for amplifying all 13 current CODIS STR loci, as well as Penta D, Penta E and amelogenin. Each primer was labeled with a fluorescent dye, and a total of three different fluorescent dyes were used to label the 16 different pairs of forward and reverse primers. Water was removed from the resulting mixture by evaporation at reduced pressure (about 0.2 atm) and ambient temperature overnight to yield a fluid mixture having a volume of about 4 μΕ. The evaporated mixture containing the PCR reagents and optionally sucrose in glycerol was stored in the PCR tube capped with a snap-on cap at 37 °C for one week. The PCR tube was kept in the dark during storage to protect the dye-labeled primers from light.

[00179] For analysis of the 13 CODIS STR loci, Penta D, Penta E and amelogenin, nuclease-free water and template DNA (about 1 ng of human genomic DNA from donor "X" or donor "Y") were added to the evaporated mixture in the PCR tube to a final volume of about 20 μΕ. Multiplex PCR was performed according to the manufacturer's recommended protocol. Those data are shown in Figure 8. Production of the amplicon products of the 16 loci was analyzed using an Applied

Biosystems 3130 Genetic Analyzer instrument (Life Technologies). Three different channels of capillary electrophoresis data are shown from top to bottom.

[00180] The data of Figure 8 show that after one week of storage at 37C in a substantially water free state, in glycerol plus sucrose or sorbitol, the resulting STR analysis obtained upon rehydration and addition of template DNA from donor X or Y is (by reference to data as in Figure 2) substantially identical to that obtained in the absence of desiccation.

[00181] It is understood that, while particular embodiments have been illustrated and described, various modifications may be made thereto and are contemplated herein. It is also understood that the disclosure is not limited by the specific examples provided herein. The description and illustration of embodiments and examples of the disclosure herein are not intended to be construed in a limiting sense. It is further understood that all aspects of the disclosure are not limited to the specific depictions, configurations or relative proportions set forth herein, which may depend upon a variety of conditions and variables. Various modifications and variations in form and detail of the embodiments and examples of the disclosure will be apparent to a person skilled in the art. It is therefore contemplated that the disclosure also covers any and all such modifications, variations and equivalents.

Claims

What Is Claimed Is:

1. A composition comprising:

b) at least one alcohol solvent selected from the group consisting of linear and branched C₂- C₆ acyclic alcohols having one or more hydroxyl groups and C₃-C₆ cyclic alcohols having one or more hydroxyl groups and three to six ring carbon atoms, wherein the acyclic alcohols and the cyclic alcohols optionally comprise one or more halide atoms;

wherein the composition is in a fluid state and is substantially free of water.

2. The composition of claim 1, wherein the at least one alcohol solvent:

is substantially soluble in water;

has a boiling point substantially greater than that of water; and

in the composition comprises no more than about 10% water by mass relative to the combined mass of water and the at least one alcohol solvent.

3. The composition of claim 1 or 2, wherein the at least one alcohol solvent comprises ethylene glycol, 1 ,2-propanediol, 1,3 -propanediol, glycerol, 1 ,2-butanediol, 1,3-butanediol, 1 ,4-butanediol, 2,3- butanediol, 1 ,2,4-butanetriol or 1,5-pentanediol, or any combination thereof.

4. The composition of any one of the preceding claims, which comprises one or more reagents for performing PCR, wherein:

the reagents for performing PCR comprise a DNA polymerase and at least one pair of a forward primer and a reverse primer for amplifying at least one nucleic acid locus; and

the at least one pair of forward primer and reverse primer optionally is labeled with a dye.

5. The composition of claim 4, wherein the at least one pair of forward and reverse primers comprises at least 5 different pairs of forward and reverse primers for amplifying at least 5 different short tandem repeat (STR) loci utilized in a forensic database, and

wherein each of the at least 5 different pairs of forward and reverse primers optionally is labeled with a dye.

6. The composition of any one of claims 1 to 3, which comprises one or more reagents for performing reverse transcription PCR (RT-PCR), wherein:

the at least one reverse transcription primer optionally is labeled with a dye and the at least one pair of forward primer and reverse primer optionally is labeled with a dye.

7. The composition of any one of claims 1 to 3, which comprises one or more reagents for performing an immunoassay, wherein:

the antibody is labeled with a dye or is conjugated to a detection protein or enzyme; and the antibody optionally is bound to a solid substrate.

8. The composition of any one of claims 1 to 3, which comprises one or more reagents for performing a sandwich immunoassay, wherein:

the reagents for performing a sandwich immunoassay comprise a first antibody that is specific for a target antigen or analyte and a second antibody that is specific for the target antigen or analyte; the second antibody is labeled with a dye or is conjugated to a detection protein or enzyme; and

the first antibody optionally is bound to a solid substrate.

9. The composition of any one of claims 1 to 3, which comprises one or more reagents for performing an enzyme-linked immunosorbent assay (ELISA), wherein the reagents for performing ELISA comprise:

a detection antibody that is specific for a target antigen or analyte and is conjugated to a detection enzyme; or

a first antibody that is specific for a target antigen or analyte, and a second antibody that is specific for the first antibody and is conjugated to a detection enzyme.

10. The composition of any one of claims 1 to 3, which comprises:

a) whole or fractionated animal blood;

b) whole or fractionated animal plasma; or c) whole or fractionated animal serum.

11. The composition of any one of claims 1 to 3, which comprises animal cells, mammalian cells, human cells, plant cells, microbial cells, pathogenic cells, bacterial cells, fungal cells, protozoan cells or viral particles, or any combination thereof, or lysates or extracts thereof.

12. The composition of any one of the preceding claims, which further comprises one or more substances selected from the group consisting of reducing agents, antioxidants, free radical scavengers, oxygen radical scavengers, hydroxyl radical scavengers, singlet oxygen quenchers, hydroperoxide -removing agents, protease inhibitors, nuclease inhibitors, ribonuclease (RNase) inhibitors, deoxyribonuclease (DNase) inhibitors, metal chelators, preservatives, anti-microbials, buffers (or buffering agents), detergents, and chaotropes.

13. The composition of claim 12, wherein the one or more substances comprise:

a) a protease inhibitor;

b) an oxygen radical scavenger;

c) a metal chelator, a hydroxyl radical scavenger, and an RNase inhibitor; or

d) a hydroxyl radical scavenger and a DNase inhibitor.

14. The composition of any one of the preceding claims, which further comprises an M⁺¹ salt or an M⁺² salt, or both.

15. The composition of any one of the preceding claims, wherein the polypeptide, the polynucleotide or the biological sample, or any combination thereof, is stable after storage at ambient temperature for at least about 2 weeks or 1 month.

16. The composition of any one of the preceding claims, wherein the polypeptide, the polynucleotide or the biological sample, or any combination thereof, retain their function or activity after storage at ambient temperature for at least about 2 weeks or 1 month.

17. A method of preserving a polypeptide, a polynucleotide or a biological sample, comprising: a) mixing an aqueous mixture comprising a polypeptide, a polynucleotide or a biological sample, or any combination thereof, with at least one alcohol solvent to produce an aqueous organic mixture, wherein:

C2-C6 acyclic alcohols having one or more hydroxyl groups and C3-C6 cyclic alcohols having one or more hydroxyl groups and three to six ring carbon atoms, wherein the acyclic alcohols and the cyclic alcohols optionally comprise one or more halide atoms; and

wherein the composition is in a fluid state and is substantially free of water.

18. The method of claim 17, wherein the at least one alcohol solvent:

is substantially soluble in water;

has a boiling point substantially greater than that of water; and

19. The method of claim 17 or 18, wherein water is removed from the aqueous organic mixture by evaporation.

20. The method of any one of claims 17 to 19, wherein removing water from the aqueous organic mixture to produce the composition in a fluid state does not pass through an intermediate solid state.

21. A composition comprising:

wherein the composition is in a fluid state and is substantially free of water.

22. The composition of claim 21, wherein the at least one ionic organic solvent:

is substantially soluble in water;

has a boiling point substantially greater than that of water; and

in the composition comprises no more than about 10% water by mass relative to the combined mass of water and the at least one ionic organic solvent.

23. The composition of claim 21 or 22, wherein the at least one ionic organic solvent is a eutectic solvent.

24. The composition of any one of claims 21 to 23, wherein the molar ratio of the organic salt to the organic hydrogen bond donor in the at least one ionic organic solvent is from about 1 : 1 to about 1 :2.

25. The composition of any one of claims 21 to 24, wherein the organic salt of the at least one ionic organic solvent comprises one or more organic salts selected from the group consisting of primary ammonium salts, secondary ammonium salts, tertiary ammonium salts, and quaternary ammonium salts.

26. The composition of claim 25, wherein the organic salt comprises a choline salt.

27. The composition of any one of claims 21 to 26, wherein the organic hydrogen bond donor of the at least one ionic organic solvent comprises one or more organic hydrogen bond donors selected from the group consisting of urea compounds, thiourea compounds, carbamates, amides, carboxylic acids, phenolic compounds, acyclic alcohols, and cyclic alcohols.

28. The composition of claim 27, wherein the organic hydrogen bond donor comprises urea, acetamide, citric acid, malonic acid, oxalic acid, ethylene glycol, 1 ,2-propanediol, 1,3-propanediol, glycerol, 1 ,2-butanediol, 1,3-butanediol, 1 ,4-butanediol, 2,3-butanediol, 1 ,2,4-butanetriol or 1,5- pentanediol, or any combination thereof.

29. The composition of any one of claims 21 to 28, which comprises one or more reagents for performing PCR, wherein:

30. The composition of claim 29, wherein the at least one pair of forward and reverse primers comprises at least 5 different pairs of forward and reverse primers for amplifying at least 5 different short tandem repeat (STR) loci utilized in a forensic database, and

31. The composition of any one of claims 21 to 28, which comprises one or more reagents for performing reverse transcription PCR (RT-PCR), wherein:

32. The composition of any one of claims 21 to 28, which comprises one or more reagents for performing an immunoassay, wherein:

33. The composition of any one of claims 21 to 28, which comprises one or more reagents for performing a sandwich immunoassay, wherein:

the first antibody optionally is bound to a solid substrate.

34. The composition of any one of claims 21 to 28, which comprises one or more reagents for performing an enzyme-linked immunosorbent assay (ELISA), wherein the reagents for performing ELISA comprise:

35. The composition of any one of claims 21 to 28, which comprises:

a) whole or fractionated animal blood;

b) whole or fractionated animal plasma; or

c) whole or fractionated animal serum.

36. The composition of any one of claims 21 to 28, which comprises animal cells, mammalian cells, human cells, plant cells, microbial cells, pathogenic cells, bacterial cells, fungal cells, protozoan cells or viral particles, or any combination thereof, or lysates or extracts thereof.

37. The composition of any one of claims 21 to 36, which further comprises one or more substances selected from the group consisting of reducing agents, antioxidants, free radical scavengers, oxygen radical scavengers, hydroxyl radical scavengers, singlet oxygen quenchers, hydroperoxide -removing agents, protease inhibitors, nuclease inhibitors, ribonuclease (RNase) inhibitors, deoxyribonuclease (DNase) inhibitors, metal chelators, preservatives, anti-microbials, buffers (or buffering agents), detergents, and chaotropes.

38. The composition of claim 37, wherein the one or more substances comprise:

a) a protease inhibitor;

b) an oxygen radical scavenger;

c) a metal chelator, a hydroxyl radical scavenger, and an RNase inhibitor; or

d) a hydroxyl radical scavenger and a DNase inhibitor.

39. The composition of any one of claims 21 to 38, which further comprises an M⁺¹ salt or an M⁺² salt, or both.

40. The composition of any one of claims 21 to 39, wherein the polypeptide, the polynucleotide or the biological sample, or any combination thereof, is stable after storage at ambient temperature for at least about 2 weeks or 1 month.

41. The composition of any one of claims 21 to 40, wherein the polypeptide, the polynucleotide or the biological sample, or any combination thereof, retain their function or activity after storage at ambient temperature for at least about 2 weeks or 1 month.

42. A method of preserving a polypeptide, a polynucleotide or a biological sample, comprising: a) mixing an aqueous mixture comprising a polypeptide, a polynucleotide or a biological sample, or any combination thereof, with at least one ionic organic solvent to produce an aqueous organic mixture, wherein:

the polypeptide comprises an enzyme that mediates a nucleic acid reaction, a polypeptide that regulates an enzyme, an antibody, a polypeptide ligand of an antibody, a polypeptide aptamer, a protein or enzyme useful for detection, a toxin, a hormone, a cytokine, a polypeptide therapeutic or a vaccine, or a derivative thereof or any combination thereof; the polynucleotide comprises a polynucleotide used in a nucleic acid reaction, a catalytic polynucleotide, or a polynucleotide that binds specifically to a target ligand, or a derivative thereof or any combination thereof;

the at least one ionic organic solvent comprises an organic salt and an organic hydrogen bond donor; and

wherein the composition is in a fluid state and is substantially free of water.

43. The method of claim 42, wherein the at least one ionic organic solvent:

is substantially soluble in water;

has a boiling point substantially greater than that of water; and

44. The method of claim 42 or 43, wherein water is removed from the aqueous organic mixture by evaporation.

45. The method of any one of claims 42 to 44, wherein removing water from the aqueous organic mixture to produce the composition in a fluid state does not pass through an intermediate solid state.

46. A container comprising the composition of any one of claims 1 to 16 and 21 to 41.

47. A kit comprising the composition of any one of claims 1 to 16 and 21 to 41.