As part of its ongoing response to the covid-19 pandemic, FDA updated the SARS CoV-2 reference panel comparative data on its website to reflect the latest information. The FDA SARS-CoV-2 reference panel is a standardized performance validation step for authorized SARS-CoV-2 molecular diagnostic tests. 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 intends to continue to update the tables on the website.
[Related: FDA Publishes Comparative Performance Data for Covid-19 Molecular Diagnostics]
As of September 30, 2020, FDA has authorized 263 tests under EUAs; these include 208 molecular tests, 51 antibody tests, and 4 antigen tests.
For more information, visit FDA.