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.
Performance MetricsIVD Knowledge Base
IVD & Molecular Diagnostics Glossary
A comprehensive glossary of in vitro diagnostics (IVD) and molecular diagnostics terminology, covering PCR terms, extraction methodology, regulatory definitions, and performance metrics.
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I
L
The lowest concentration of an analyte that can be quantified with acceptable accuracy and precision under stated conditions — distinct from, and higher than, the limit of detection.
Performance MetricsP
How close amplification is to ideal doubling each cycle, reported as a percentage or derived from the standard curve slope. Efficiency near 90–110% with a linear standard curve supports quantification claims; it is a standard checklist item when auditing assay validation dossiers.
Performance MetricsR
Complementary precision measures: repeatability is variation under the same conditions (same operator, equipment, short interval); reproducibility is variation across conditions — different days, operators, lots, or laboratories.
Performance Metrics