Wednesday, December 2, 2020

FDA Updates SARS-CoV-2 Reference Panel Comparative Data

The reference panel allows for a more precise comparison of analytical performance of molecular IVD assays intended to detect SARS-CoV-2.

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US Food and Drug Administration

FDA Updates SARS-CoV-2 Reference Panel Comparative Data

On December 2, 2020, the U.S. Food and Drug Administration (FDA) updated the SARS CoV-2 reference panel comparative data on FDA's 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, comprised 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). 

See Reference Panel Data Update

Questions?

If you have questions, please email COVID19DX@fda.hhs.gov.


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