FDA issues guidance on the impact of SARS-CoV-2 variants on test performance

Feb. 23, 2021

The U.S. Food and Drug Administration (FDA) issued a new guidance for test developers to provide information on evaluating the potential impact of SARS-CoV-2 genetic mutations on COVID-19 tests.

The FDA noted that it had already issued a safety alert to caution that the presence of viral genetic mutations in a patient sample can potentially change the performance of a diagnostic test. The FDA identified a few tests that are known to be impacted by emerging viral mutations but has also said the impact does not appear as yet to be significant.

The FDA said the clinical impact of viral genetic mutations on a test’s performance is influenced by various factors, such as the sequence of the variant, the design of test (for example, molecular tests designed to detect multiple SARS-CoV-2 genetic targets are less susceptible to the effects of genetic variation than tests designed to detect a single genetic target), and the prevalence of the variant in the patient population.

The FDA said it is taking steps to understand the public health impact of the virus on test performance, such as monitoring publicly available genomic databases for emerging SARS-CoV-2 genetic mutations and the potential effects of genetic variation on molecular tests that have been issued an EUA.

The FDA recommends that test developers conduct routine monitoring to evaluate the potential impact of new and emerging viral genetic mutations on the performance for molecular, antigen and serology SARS-CoV-2 tests.

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