The effect of viral mutation remains poor on molecular tests: US FDA

The US Food and Drug Administration warns clinical laboratory personnel and health care providers that the FDA is monitoring the possible effect on approved molecular SARS-CoV-2 tests of viral mutations, including an emerging variant from the UK known as the B.1.1.7 variant, and that false negative results will occur with any molecular test for SARS-CoV-2 detection if a mutation occurs

The FDA is taking additional steps to ensure that approved studies remain accurate by partnering with test developers and undertaking ongoing data analysis to review all currently authorised molecular tests, as per a statement from the agency.

In order to ensure that approved studies continue to provide patients with reliable results, the FDA will continue to track SARS-CoV-2 genetic viral variants,” said FDA Commissioner Stephen M. Hahn, M.D.

"While these activities continue, we are collaborating with licenced test developers and reviewing incoming data to ensure that health care professionals and clinical personnel can easily and reliably identify patients infected with SARS-CoV-2, particularly those with emerging genetic variants.

At this time, we assume that the data indicate that COVID-19 vaccines currently approved could still be effective against this strain. The FDA will continue to notify health care providers and the public of any new information.

Throughout the pandemic, the FDA has been tracking SARS-CoV-2 viral mutations and their possible effects on testing. The presence in a patient population of SARS-CoV-2 genetic variants will potentially affect the performance of the SARS-CoV-2 test. Genetic variation in the SARS-CoV-2 genome could have less effect on tests that rely on the detection of multiple genome regions than on tests that rely on the detection of only one region.