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

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FDA Publishes New Webpage That Consolidates Information About How SARS-CoV-2 Variants Impact COVID-19 Tests

FDA maze of regulations

New FDA webpage provides new information about how SARS-CoV-2 variants impact COVID-19 testing and how clinical laboratories can respond

The emergence of new SARS-CoV-2 variants is becoming increasingly recognized as an important component in the COVID-19 response. This is because SARS-CoV-2 variants have been shown to affect certain COVID-19 tests, treatments, and vaccines.

While no COVID-19 test has been shown to completely fail to detect certain SARS-CoV-2 variants, several tests have been impacted. These developments have warranted continued research into mutations of the SARS-CoV-2 virus and, subsequently, new and important information that clinical laboratories and other healthcare professionals need.

The US Food and Drug Administration (FDA) has provided this information as more has become known about how emerging SARS-CoV-2 variants affect testing. However, the information has been fragmented, and accessing consolidated information has been difficult.

To correct this problem, the FDA has launched a new webpage that serves as a comprehensive resource about the impact of SARS-CoV-2 variants on COVID-19 testing. The webpage provides a high-level overview of variant-related information that clinicians should be aware of, as well as information about individual tests.

As of the beginning of April, the FDA SARS-CoV-2 Viral Mutations webpage contained information about four different tests that have been impacted by the emergence of viral variants. More tests are expected to be added as new information and research become available and as mutations occur.

Clinical laboratory leaders will benefit from this new resource as the most comprehensive and up-to-date FDA information on the COVID-19 testing impacts of viral variants.

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