COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

COVID-19 Briefings

Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

FDA Updates SARS-CoV-2 Viral Mutation Page to Include Effects of New Variant on Mesa Biotech’s Accula SARS-CoV-2 Test

FDA maze of regulations

SARS-CoV-2 variants continue to create new impacts on some COVID-19 tests, FDA warns

The US Food and Drug Administration (FDA) released an update to its SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests webpage that provides an up-to-date record of the various COVID-19 tests that are affected by SARS-CoV-2 variants and how clinical providers should adjust their usage of tests that are affected by these variants.

The most recent update was released June 3, 2021, and provides new information on the potential impact of the performance of the Mesa Biotech Inc. Accula SARS-CoV-2 Test. The FDA warns healthcare providers, “performance may be impacted when a SARS-CoV-2 patient sample having certain viral mutations is tested.” The FDA further explains, “While the impact does not appear to be significant, the FDA is providing this information out of an abundance of caution.”

The FDA does not recommend against continuing to use the Accula SARS-CoV-2 Test to diagnose COVID-19, but the FDA does provide recommendations for laboratory staff and healthcare providers using the test. These recommendations include being aware that certain variants may affect test results and noting that the current instructions for use for the Accula SARS-CoV-2 Test do not reflect this new impact by certain SARS-CoV-2 variants.

Clinical laboratories that use the Accula SARS-CoV-2 Test can review the entirety of the FDA’s findings and recommendations, as well as other tests impacted by SARS-CoV-2 variants, here.

Related Resources:

FDA EUA Letter: Accula SARS-CoV-2 Test