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IVD Test Reagent/Kits, Molecular Assay

Definition : Reagents designed for use in a diverse range of sensitive and specific clinical assays primarily based on the principles of the chemistry and structure of nucleic acid molecules. These assays rely on a thorough knowledge of the DNA and/or RNA sequences relevant to each diagnostic system. Molecular reagents are used in one or more of many different assays that manipulate nucleic acids (e.g., nucleic acid hybridization), using either amplification (e.g., polymerase chain reaction, self-sustained replication) or nonamplification (e.g., Southern blotting of DNA, restriction fragment-length polymorphisms) techniques. Molecular reagents are mostly used in assays to detect infectious agents (e.g., bacteria, viruses) and/or to identify genetic disorders either inborn or acquired (e.g., tumor markers). Frequently, these reagents are available in kits that include the nucleic acid probe (e.g., cloned, oligonucleotide, genomic) and all other reagents (e.g., primers, buffers, salts, denaturants) needed to perform the assay.

Entry Terms : "Nucleic Acid Test Reagents" , "Molecular Assay Reagents" , "Reagents, Molecular Assay"

UMDC code : 19236

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