USA – FDA clarifies pooled sample, multi-analyte coronavirus EUAs

Developers of multi-analyte respiratory panels that include a test for SARS-CoV-2, the novel coronavirus, can request emergency use authorizations (EUAs) from the US Food and Drug Administration (FDA), the agency clarified this week.
In updates to its frequently asked questions (FAQ) webpage on SARS-CoV-2 testing, the agency said that multi-analyte respiratory panels that include SARS-COV-2 are eligible for emergency use authorization, noting “the overlap in signs and symptoms between SARS-CoV-2 and other respiratory viral infections, including influenza.” Citing increased speed and efficient use of resources, the FAQ adds that “These panels are useful when multiple respiratory pathogens are circulating at the same time, as is expected with the upcoming flu season.”
FDA will consider the intended use of the test, including fit within the emergency declaration of the Department of Health and Human Services and current public health recommendations for patient testing. The agency will also consider thin vitro diagnostic (IVD) status of the other components of the multi-analyte panel. Laboratories and commercial manufacturers should refer to their respective molecular diagnostic templates for validation recommendations and to determine what should be included in the EUA request…