Posted by Michael Wonder on 15 Sep 2020
FDA publishes comparative performance data for COVID-19 molecular diagnostic tests
15 September 2020 - Today, the U.S. FDA published comparative performance data for some authorised COVID-19 molecular diagnostic tests.
The tables show the limit of detection of more than 55 authorised molecular diagnostic COVID-19 tests against a standardised sample panel provided by the FDA.
The FDA provided these standardised samples, known as a reference panel, 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 Authorisation.
