FDA updates performance data for molecular tests to diagnose COVID-19 virus

The Food and Drug Administration yesterday posted updated comparative performance data for molecular tests to diagnose the COVID-19 virus.

Test developers, in order to receive emergency use authorization, are required to assess their test’s performance against a reference panel of viral samples.

In FDA’s data, a lower product LoD (limit of detection) indicates a test’s ability to detect a smaller amount of viral material in a given sample, signaling a more sensitive test. FDA updates the data as it receives additional results to help inform laboratories, health care providers and patients about the relative performance of available tests.