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Glossary Term
Validation evidence that an assay detects the range of variants, genotypes, or serotypes it claims to cover. For evolving targets such as influenza or SARS-CoV-2, inclusivity statements carry a validation date and should be checked against circulating variant lists at procurement time.
Glossary Term
A two-step setup in which RNA is first copied into complementary DNA by a reverse transcriptase and then amplified by PCR. Used for RNA viruses such as influenza, RSV, SARS-CoV-2, and HCV. In procurement documents, confirm whether "RT-PCR" refers to real-time (quantitative) or endpoint (qualitative) reading.
