SARS-CoV-2 nucleic acid IVD, control

This category includes control materials used to verify the performance of in vitro diagnostic assays that detect SARS-CoV-2 nucleic acid in clinical specimens. These controls are not diagnostic tests themselves but are used alongside them to ensure the assay is functioning correctly during testing runs.

Such control materials are typically supplied as stabilized, non-infectious preparations that mimic target nucleic acid and are used to monitor assay sensitivity, specificity, and reproducibility. They are regulated as in vitro diagnostic medical devices and are intended for use by laboratories performing SARS-CoV-2 nucleic acid testing.