Analyte-specific reagent
Analyte-specific reagents (ASRs) are a class of biological molecules which can be used to identify and measure the amount of an individual chemical substance in biological specimens.
Regulatory definition
The U.S. Food and Drug Administration (FDA) defines analyte specific reagents (ASRs) in 21 CFR 864.4020 as “antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended to use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.”
In simple terms an analyte specific reagent is the active ingredient of an in-house test.
gollark: That would still need a lot of GPU runtime.
gollark: Also, anyone got ideas for achievements and/or interesting metrics to track for achievements?
gollark: Or, as I said, a big dataset yet.
gollark: Oh, right. I could maybe use GPT-2 but I don't have anything with a powerful GPU.
gollark: What are you on about?
External links
- Guidance for Industry and FDA Staff - Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
- Code of Federal Regulations - Specimen Preparation Reagents (21CFR864.4020)
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