WO2008111981A1 - Compositions, systèmes, et procédés permettant la préservation de macromolécules - Google Patents

Compositions, systèmes, et procédés permettant la préservation de macromolécules Download PDF

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Publication number
WO2008111981A1
WO2008111981A1 PCT/US2007/063982 US2007063982W WO2008111981A1 WO 2008111981 A1 WO2008111981 A1 WO 2008111981A1 US 2007063982 W US2007063982 W US 2007063982W WO 2008111981 A1 WO2008111981 A1 WO 2008111981A1
Authority
WO
WIPO (PCT)
Prior art keywords
acid
macromolecule
stabilizing composition
chelator
bis
Prior art date
Application number
PCT/US2007/063982
Other languages
English (en)
Inventor
Tony Baker
Original Assignee
Sierra Molecular Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sierra Molecular Corporation filed Critical Sierra Molecular Corporation
Priority to PCT/US2007/063982 priority Critical patent/WO2008111981A1/fr
Priority to PCT/US2008/057081 priority patent/WO2008113017A2/fr
Priority to KR1020097021463A priority patent/KR20100015578A/ko
Priority to EP08732260A priority patent/EP2129780A2/fr
Priority to JP2009553822A priority patent/JP2010535013A/ja
Priority to AU2008224883A priority patent/AU2008224883A1/en
Priority to CA002680801A priority patent/CA2680801A1/fr
Publication of WO2008111981A1 publication Critical patent/WO2008111981A1/fr
Priority to US12/569,542 priority patent/US20100120078A1/en
Priority to US13/016,706 priority patent/US20110165610A1/en
Priority to US13/897,833 priority patent/US20140072976A1/en

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/10—Processes for the isolation, preparation or purification of DNA or RNA
    • C12N15/1003—Extracting or separating nucleic acids from biological samples, e.g. pure separation or isolation methods; Conditions, buffers or apparatuses therefor
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • A01N1/0205—Chemical aspects
    • A01N1/021—Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • A01N1/0205—Chemical aspects
    • A01N1/021—Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
    • A01N1/0215—Disinfecting agents, e.g. antimicrobials for preserving living parts
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • A01N1/0205—Chemical aspects
    • A01N1/021—Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
    • A01N1/0226—Physiologically active agents, i.e. substances affecting physiological processes of cells and tissue to be preserved, e.g. anti-oxidants or nutrients
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6806—Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay

Definitions

  • Degradation of a macromolecule and/or biomolecule may be reduced by lowering the temperature of the macromolecule or biomolecule.
  • this option may not be available in all situations or it may not be available for a sufficiently long period of time (e.g., from the time of sample collection to the time of analysis).
  • a sample is collected (e.g., from a patient) in a remote location, it may be difficult or impossible to preserve the target molecule long enough for the sample to be transported to a facility where the sample is analyzed.
  • cooling may not be uniform across all samples and/or may not be consistent from experiment to experiment.
  • a macromolecule and/or a biomolecule may include a protein and/or a nucleic acid (e.g., DNA and RNA).
  • a nucleic acid may include sequences from a plurality of sources.
  • a macromolecule to be preserved and/or stabilized with a macromolecule stabilizing composition and/or method may include, according to some embodiments, a nucleic acid selected from the group consisting of DNA, RNA, mRNA, and cDNA.
  • a nucleic acid may include, for example, prokaryotic and/or eukaryotic DNA.
  • a macromolecule to be preserved and/or stabilized with a macromolecule stabilizing composition and/or method may be present in a bodily fluid obtained from a human subject.
  • a bodily fluid may include, for example, a material selected from the group consisting of blood, blood serum, amniotic fluid, spinal fluid, conjunctival fluid, salivary fluid, vaginal fluid, stool, seminal fluid, and sweat.
  • a macromolecule stabilizing system may include a sample container configured and arranged to receive and contain a sample comprising the macromolecule and a macromolecule stabilizing composition (e.g., including a chelator, at least one chelator enhancing component, and a base).
  • a system may also include user instructions in some embodiments.
  • the sample container in some embodiments, may contain the macromolecule stabilizing composition.
  • the sample container may include at least one inner surface and at least one outer surface with a macromolecule stabilizing composition coated onto the latter.
  • a sample container may include at least one vesicle, liposome, and/or micelle in some embodiments.
  • a macromolecule stabilizing composition may be present within the lumen of a vesicle, liposome, and/or micelle.
  • Figure 12A is a chart showing a representation of results obtained from an example PCR amplification using MD03 and MD06 primers and a hepatitis B template in serum contacted with buffer (no protection), guanidine only, EGTA only, or EGTA+guanidine;
  • Figure 14C is a chart showing the results of an example PCR amplification using a gonococcal DNA template in fresh urine contacted with thymine only or sodium thiocyanate+EDTA+thymine;
  • RNA polymerase a purine base and/or a pyrimidine base may bind to a nucleic acid and act as an isomeric target for one or more enzymes that degrade DNA and/or RNA.
  • the yield from PCR amplification of a target nucleic acid (e.g., gonococcal DNA) contacted with a macromolecule stabilizing composition having purine base may be at least about 2-fold higher, about 3-fold higher, about 4-fold higher, about 5-fold higher, about 6-fold higher, about 7-fold higher, about 8-fold higher, about 9-fold higher, and/or 10-fold higher than the yield from PCR amplification of the same target nucleic acid not contacted with a macromolecule stabilizing composition having a purine base.
  • a chelator may be included at a concentration of up to about 0.001 M, up to about 0.005 M, up to about 0.01 M, up to about 0.05 M, and/or up to about 0.1 M.
  • a chelator may be included at a concentration of from about 0.001 M to about 0.1 M. Where two or more chelators are included in a single composition, either the concentration of each chelator or the total concentration of the combined chelators may fall within any of the provided ranges.
  • a chelator may include EDTA, EGTA, BAPTA, imidazole, iminodiacetate (IDA), bis(5- amidino-2-benzimidazolyl)methane (BABIM), and/or salts thereof.
  • a pyrimidine base may be included at a concentration of up to about 0.1 M, up to about 0.25 M, up to about 0.5 M, up to about 0.75 M, up to about 1 M, up to about 1.5 M, up to about 2 M, up to about 2.5 M, up to about 3 M, up to about 4 M, up to about 5 M, up to about 6 M, and/or up to about 7 M.
  • a pyrimidine base, if included, may be present at a concentration within a range having endpoints defined by any of the foregoing concentrations.
  • a buffer may include potassium acetate, sodium acetate, potassium phosphate, sodium phosphate, Tris, N-(2-hydroxyethyl)piperazine-N'-(2-ethanesulfonic acid) (HEPES) buffer, 3-(N-morpholino)propane sulfonic acid (MOPS) buffer, 2-[(2-amino-2- oxoethyl)amino]ethanesulfonic acid (ACES) buffer, N-(2-acetamido)2-iminodiacetic acid buffer (ADA), 3-[(l,l-dimethyl-2-hydroxyethyl)amino]-2-propanesulfonic acid (AMPSO) buffer, N,N-bis(2-hydroxyethyl)-2-aminoethanesulfonic acid (BES) buffer, Bicine (N,N- bis(2-hydroxyethylglycine) buffer, bis-(2-hydroxyethyl)imino-tris(hydroxymethyl)
  • the supernatant was decanted, and the pellet was suspended in 1 mL phosphate buffer.
  • the pellet was suspended in 10 mL of 70% alcohol and centrifuged.
  • a macromolecule stabilizing composition may be added to a bodily fluid, e.g., a urine specimen
  • a urine specimen may also be added to a macromolecule stabilizing composition without detriment to the efficacy of preservation/stabilization.
  • Optimal preservation of the DNA may be achieved by adding a single macromolecule stabilizing composition of the disclosure to a specimen.
  • This PCR assay for PPNG takes advantage of the fact that the TEM-I gene is located close to the end of the transposon Tn2; by the use of one primer in the TEM-I gene and the other in a sequence beyond the end of Tn2, and common to all four plasmids, a PCR product only from plasmids and not from TEM-I encoding plasmids was obtained. (Table 3, below) The conditions associated with this protocol were modified to include the macromolecule stabilizing composition in the hybridization and the treated probe was mixed with the 761-bp amplification product per standard PCR protocol. The results were read at A 450 nm.
  • compositions comprising sodium perchlorate, lithium chloride, guanidine HCl, guanidine thiocyanate, EDTA, EGTA, BAPTA, and/or adenine were prepared.
  • Fresh samples of human urine were collected, spiked with 1 pg of gonococcal DNA, combined with one of the recited compositions, and incubated at room temperature. Aliquots were removed after 8 hours and tested by PCR for the presence of amplifiable gonococcal DNA. The PCR protocol was the same as described in Example 10.
  • compositions with a chelator, a chelator enhancing component, and adenine stabilized gonococcal DNA in urine more effectively than compositions with fewer than all three components.

Abstract

L'invention concerne des compositions, des systèmes et des procédés permettant de préserver et/ou de stabiliser une macromolécule et/ou une biomolécule. Une composition de stabilisation de macromolécule peut comprendre un agent chélatant, un composant d'amélioration d'agent chélatant, et une base (par exemple, une base de purine ou une base de pyrimidine). Un procédé de stabilisation de macromolécule peut comprendre la mise en contact d'une macromolécule avec une composition de stabilisation de macromolécule. Un système de stabilisation de macromolécule peut comprendre un contenant approprié pour recevoir un échantillon contenant une macromolécule et/ou une biomolécule et une composition de stabilisation de macromolécule. Une macromolécule et/ou une biomolécule peut être préservée et/ou stabilisée dans des conditions ambiantes (par exemple sans réfrigération). Une macromolécule et/ou une biomolécule peut comprendre une protéine et/ou un acide nucléique.
PCT/US2007/063982 2001-08-16 2007-03-14 Compositions, systèmes, et procédés permettant la préservation de macromolécules WO2008111981A1 (fr)

Priority Applications (10)

Application Number Priority Date Filing Date Title
PCT/US2007/063982 WO2008111981A1 (fr) 2007-03-14 2007-03-14 Compositions, systèmes, et procédés permettant la préservation de macromolécules
PCT/US2008/057081 WO2008113017A2 (fr) 2007-03-14 2008-03-14 Compositions, systèmes et procédés de conservation et/ou de stabilisation d'une cellule et/ou d'une macromolécule
KR1020097021463A KR20100015578A (ko) 2007-03-14 2008-03-14 세포 및/또는 거대분자의 보존 및/또는 안정화를 위한 조성물, 시스템 및 방법
EP08732260A EP2129780A2 (fr) 2007-03-14 2008-03-14 Compositions, systèmes et procédés de conservation et/ou de stabilisation d'une cellule et/ou d'une macromolécule
JP2009553822A JP2010535013A (ja) 2007-03-14 2008-03-14 細胞および／または高分子の保存および／または安定化のための組成物、システムおよび方法
AU2008224883A AU2008224883A1 (en) 2007-03-14 2008-03-14 Compositions, systems, and methods for preservation and/or stabilization of a cell and/or macromolecule
CA002680801A CA2680801A1 (fr) 2007-03-14 2008-03-14 Compositions, systemes et procedes de conservation et/ou de stabilisation d'une cellule et/ou d'une macromolecule
US12/569,542 US20100120078A1 (en) 2001-08-16 2009-09-29 Urine Stabilization System
US13/016,706 US20110165610A1 (en) 2007-03-14 2011-01-28 Compositions, systems, and methods for preservation and/or stabilization of a cell and/or macromolecule
US13/897,833 US20140072976A1 (en) 2001-08-16 2013-05-20 Urine stabilization system

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2007/063982 WO2008111981A1 (fr) 2007-03-14 2007-03-14 Compositions, systèmes, et procédés permettant la préservation de macromolécules

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US68616907A Continuation-In-Part 2007-03-14 2007-03-14
US4896108A Continuation-In-Part 2001-08-16 2008-03-14

Publications (1)

Publication Number Publication Date
WO2008111981A1 true WO2008111981A1 (fr) 2008-09-18

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Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010003037A2 (fr) * 2008-07-03 2010-01-07 Sierra Molecular Corporation Compositions, systèmes, et procédés de stabilisation d’une cellule et/ou d’une macromolécule
WO2011151427A1 (fr) * 2010-06-02 2011-12-08 Qiagen Gmbh Stabilisation d'acides nucléiques dans des échantillons biologiques contenant de la matière cellulaire
WO2015191633A1 (fr) 2014-06-10 2015-12-17 Biomatrica, Inc. Stabilisation de polypeptides non dénaturés, d'acides nucléiques, et d'exosomes dans un échantillon de sang à des températures ambiantes
EP3064597A1 (fr) * 2015-03-05 2016-09-07 Streck, Inc. Stabilisation d'acides nucléiques dans l'urine
US9445586B2 (en) 2013-03-15 2016-09-20 Truckee Applied Genomics, Llc Methods and reagents for maintaining the viability of cancer cells in surgically removed tissue
US9926590B2 (en) 2009-02-18 2018-03-27 Streck, Inc. Devices and compositions for preservation of cell-free nucleic acids
US10091984B2 (en) 2013-07-24 2018-10-09 Streck, Inc. Compositions and methods for stabilizing circulating tumor cells
CN112575063A (zh) * 2020-12-30 2021-03-30 华南理工大学 一种全血基因组dna保存剂及其制备方法与应用
US10966421B2 (en) 2002-10-16 2021-04-06 Streck, Inc. Method and device for collecting and preserving cells for analysis
US11299764B2 (en) 2015-11-20 2022-04-12 Streck, Inc. Single spin process for blood plasma separation and plasma composition including preservative
AT17499U1 (de) * 2020-09-18 2022-06-15 Procomcure Biotech Gmbh Kit zur Entnahme von Speichelproben
US11506655B2 (en) 2016-07-29 2022-11-22 Streck, Inc. Suspension composition for hematology analysis control
US11634747B2 (en) 2009-01-21 2023-04-25 Streck Llc Preservation of fetal nucleic acids in maternal plasma

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WO1999029904A2 (fr) * 1997-12-10 1999-06-17 Sierra Diagnostics, Inc. Procedes et reactifs de conservation de l'adn de fluides corporels
EP1207208A2 (fr) * 2000-11-15 2002-05-22 Becton Dickinson and Company Méthode pour la préservation des cellules et des acides nucléiques cibles
WO2003067978A2 (fr) * 2002-02-13 2003-08-21 Biosafe Medical Technologies, Inc. Composition de stabilisation de fluide biologique et son procede d'utilisation
EP1584923A2 (fr) * 2004-04-07 2005-10-12 Roche Diagnostics GmbH Stabilisation de biomolecules dans des échantillons
US20060014214A1 (en) * 2004-05-25 2006-01-19 Sierra Diagnostics, Llc Urine preservation system

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999029904A2 (fr) * 1997-12-10 1999-06-17 Sierra Diagnostics, Inc. Procedes et reactifs de conservation de l'adn de fluides corporels
US20020102570A1 (en) * 1997-12-10 2002-08-01 Sierra Diagnostics, Inc. Methods and reagents for preservation of DNA in bodily fluids
EP1207208A2 (fr) * 2000-11-15 2002-05-22 Becton Dickinson and Company Méthode pour la préservation des cellules et des acides nucléiques cibles
WO2003067978A2 (fr) * 2002-02-13 2003-08-21 Biosafe Medical Technologies, Inc. Composition de stabilisation de fluide biologique et son procede d'utilisation
EP1584923A2 (fr) * 2004-04-07 2005-10-12 Roche Diagnostics GmbH Stabilisation de biomolecules dans des échantillons
US20060014214A1 (en) * 2004-05-25 2006-01-19 Sierra Diagnostics, Llc Urine preservation system

Cited By (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11647743B2 (en) 2002-10-16 2023-05-16 Streck Llc Method and device for collecting and preserving cells for analysis
US10966421B2 (en) 2002-10-16 2021-04-06 Streck, Inc. Method and device for collecting and preserving cells for analysis
WO2010003037A3 (fr) * 2008-07-03 2010-02-25 Sierra Molecular Corporation Compositions, systèmes, et procédés de stabilisation d’une cellule et/ou d’une macromolécule
WO2010003037A2 (fr) * 2008-07-03 2010-01-07 Sierra Molecular Corporation Compositions, systèmes, et procédés de stabilisation d’une cellule et/ou d’une macromolécule
US11634747B2 (en) 2009-01-21 2023-04-25 Streck Llc Preservation of fetal nucleic acids in maternal plasma
US11761025B2 (en) 2009-02-18 2023-09-19 Streck Llc Preservation of cell-free nucleic acids
US10144955B2 (en) 2009-02-18 2018-12-04 Streck, Inc. Methods for preservation of cell-free nucleic acids
US9926590B2 (en) 2009-02-18 2018-03-27 Streck, Inc. Devices and compositions for preservation of cell-free nucleic acids
US10689686B2 (en) 2009-02-18 2020-06-23 Streck, Inc. Preservation of cell-free nucleic acids
US20180216165A1 (en) 2009-02-18 2018-08-02 Streck, Inc. Preservation of cell-free nucleic acids
US10294513B2 (en) 2009-02-18 2019-05-21 Streck, Inc. Preservation of cell-free nucleic acids
US20130137586A1 (en) * 2010-06-02 2013-05-30 Qiagen Gmbh Stabilization of nucleic acids in cell material-containing biological samples
WO2011151427A1 (fr) * 2010-06-02 2011-12-08 Qiagen Gmbh Stabilisation d'acides nucléiques dans des échantillons biologiques contenant de la matière cellulaire
US9565852B2 (en) 2013-03-15 2017-02-14 Truckee Applied Genomics, Llc Methods and reagents for maintaining the viability of cancer cells in surgically removed tissue
US9949474B2 (en) 2013-03-15 2018-04-24 Truckee Applied Genomics, Llc Methods and reagents for maintaining the viability of cancer cells in surgically removed tissue
US10772318B2 (en) 2013-03-15 2020-09-15 Truckee Applied Genomics, Llc Methods and reagents for maintaining the visability of cancer cells in surgically removed tissue
US9445586B2 (en) 2013-03-15 2016-09-20 Truckee Applied Genomics, Llc Methods and reagents for maintaining the viability of cancer cells in surgically removed tissue
US11547111B2 (en) 2013-07-24 2023-01-10 Streck, Inc. Compositions and methods for stabilizing circulating tumor cells
US10674721B2 (en) 2013-07-24 2020-06-09 Streck, Inc. Compositions and methods for stabilizing circulating tumor cells
US10091984B2 (en) 2013-07-24 2018-10-09 Streck, Inc. Compositions and methods for stabilizing circulating tumor cells
WO2015191633A1 (fr) 2014-06-10 2015-12-17 Biomatrica, Inc. Stabilisation de polypeptides non dénaturés, d'acides nucléiques, et d'exosomes dans un échantillon de sang à des températures ambiantes
EP3155395A4 (fr) * 2014-06-10 2018-04-18 Biomatrica, INC. Stabilisation de polypeptides non dénaturés, d'acides nucléiques, et d'exosomes dans un échantillon de sang à des températures ambiantes
US11168351B2 (en) 2015-03-05 2021-11-09 Streck, Inc. Stabilization of nucleic acids in urine
EP3064597A1 (fr) * 2015-03-05 2016-09-07 Streck, Inc. Stabilisation d'acides nucléiques dans l'urine
US11299764B2 (en) 2015-11-20 2022-04-12 Streck, Inc. Single spin process for blood plasma separation and plasma composition including preservative
US11506655B2 (en) 2016-07-29 2022-11-22 Streck, Inc. Suspension composition for hematology analysis control
AT17499U1 (de) * 2020-09-18 2022-06-15 Procomcure Biotech Gmbh Kit zur Entnahme von Speichelproben
CN112575063A (zh) * 2020-12-30 2021-03-30 华南理工大学 一种全血基因组dna保存剂及其制备方法与应用

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