Resource: SARS CoV-2 Reference Panel
Source: U.S. Food and Drug Administration
Synopsis: On Dec. 2, the FDA updated the SARS CoV-2 reference panel comparative data on our website to reflect the latest information. The FDA SARS-CoV-2 reference panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical purposes. The reference panel allows for a more precise comparison of the analytical performance of different molecular in vitro diagnostic (IVD) assays intended to detect SARS-CoV-2. The FDA provided the panel, composed of standardized samples, to test developers who are required to assess their test’s performance against this panel (or other FDA-recommended reference materials) as a condition of their emergency use authorization (EUA).
Comment: The FDA SARS-CoV-2 Reference Panel allows for a more precise comparison of the analytical performance of different molecular in vitro diagnostic (IVD) assays intended to detect SARS-CoV-2. The Reference Panel contains common, independent, and well-characterized reference material that is available to developers of SARS-CoV-2 nucleic acid-based amplification tests (NAATs) for which Emergency Use Authorization (EUA) was requested.
