Classifications

• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
  • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
  • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
  • G01N33/5306—Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
  • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
  • G01N33/94—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
  • G01N33/9493—Immunosupressants

Definitions

• analyte also included within the term analyte are metabolites related to disease states, aminoglycosides, such as gentamicin, kanamicin, tobramycin, and amikacin, and pesticides such as, for example, polyhalogenated biphenyls, phosphate esters, thiophosphates, carbamates and polyhalogenated sulfenamides and their metabolites and derivatives.
• aminoglycosides such as gentamicin, kanamicin, tobramycin, and amikacin
• pesticides such as, for example, polyhalogenated biphenyls, phosphate esters, thiophosphates, carbamates and polyhalogenated sulfenamides and their metabolites and derivatives.
• Non-ionic detergents that may be employed as the hemolytic agent include both synthetic detergents and natural detergents.
• synthetic detergents include TRITONTM X-100, TRITONTM N-101, TRITONTM X-114, TRITONTM X-405, TRITONTM SP-135, TWEEN® 20 (polyoxyethylene (20) sorbitan monolaurate), TWEEN® 80 (polyoxyethylene (20) sorbitan monooleate), DOWFAX®, ZONYL®, pentaerythrityl palmitate, ADOGEN® 464, ALKANOL® 6112 surfactant, allyl alcohol 1,2-butoxylate-block-ethoxylate HLB 6, BRIJ®, ethylenediamine tetrakis(ethoxylate-block-propoxylate) tetrol, IGEPAL®, MERPOL®, poly(ethylene glycol), 2-[ethyl[(heptadecafluorooctyl)sulfonyl]
• the amount of the releasing agent in the aqueous medium is about 0.000001% to about 0.5%, about 0.0001% to about 0.4%, about 0.001% to about 0.3%, about 0.01% to about 0.2%, about 0.1% to about 0.3%, about 0.2% to about 0.5%, about 0.1% to about 0.2%, for example (percent is weight/volume).
• One or more incubation periods may be employed in the methods in accordance with the principles described herein.
• An incubation period may be applied to a medium at one or more intervals including any intervals between additions of various reagents mentioned above.
• the medium is usually incubated at a temperature and for a time sufficient for the function that is being carried out such as, for example, treatment with a releasing agent, treatment with a pretreatment agent, binding of various components of the reagents such as, for example, binding of antibody to an analyte, to occur.
• Moderate temperatures are normally employed for carrying out an incubation period.
• the method may include an incubation period for one or more of the steps of the present methods.
• the examination of the medium involves detection of a signal from the medium.
• the presence and/or amount of the signal are related to the presence and/or amount of the analyte in the sample.
• the particular mode of detection depends on the nature of the sps.
• a label of an sps can produce a signal detectable by external means, desirably by visual examination, and include, for example, electromagnetic radiation, electrochemistry, heat, radioactivity detection, and chemical reagents.
• the examination for presence and/or amount of the signal also includes the detection of the signal, which is generally merely a step in which the signal is read.
• the signal is normally read using an instrument, the nature of which depends on the nature of the signal.
• the instrument may be a spectrophotometer, fluorometer, absorption spectrometer, luminometer, chemiluminometer, actinometer, photographic instrument, and the like.
• the presence and amount of signal detected is related to the presence and amount of the analyte present in a sample if the assay is making an accurate determination. Temperatures during measurements generally range from about 10° to about 70° C. or from about 20° to about 45° C., or about 20° to about 25° C., for example. In one approach standard curves are formed using known concentrations of the analytes to be screened. As discussed herein, calibrators and other controls may also be used.
• Antibodies specific for an analyte for use in immunoassays can be monoclonal or polyclonal. Such antibodies can be prepared by techniques that are well known in the art such as immunization of a host and collection of sera (polyclonal) or by preparing continuous hybrid cell lines and collecting the secreted protein (monoclonal) or by cloning and expressing nucleotide sequences or mutagenized versions thereof coding at least for the amino acid sequences required for specific binding of natural antibodies.
• Antibodies may include a complete immunoglobulin or fragment thereof, which immunoglobulins include the various classes and isotypes, such as IgA, IgD, IgE,
• homogeneous non-agglutination immunoassays may be employed; such assays may also be referred to as essentially partition-free immunoassays.
• the present methods have application to fully automated homogeneous assays in which, prior to the assay, there is no extraction or separation of the analyte from other constituents of the sample including analyte metabolites.
• a sample such as a whole blood sample, without extraction in, e.g., an organic solvent, is combined with reagents for conducting an assay for the analyte in a suitable medium and the assay method is conducted.
• the present methods also find application to manual extraction assays.

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• Bioinformatics & Cheminformatics (AREA)
• Pharmacology & Pharmacy (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Investigating Or Analysing Biological Materials (AREA)

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• 2014
  • 2014-12-10 JP JP2016538045A patent/JP6559135B2/ja active Active
  • 2014-12-10 US US15/103,534 patent/US20160313310A1/en not_active Abandoned
  • 2014-12-10 EP EP14870173.3A patent/EP3080604B1/en active Active
  • 2014-12-10 WO PCT/US2014/069520 patent/WO2015089172A1/en not_active Ceased
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• 2018
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• 2020
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• 2023
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• 2024
  • 2024-09-06 US US18/826,402 patent/US20240426814A1/en active Pending

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