FDA Clarifies EUAs for COVID Multi-Analyte Respiratory Panels

Manufacturers can request emergency use authorizations under the public health emergency of the coronavirus pandemic for multi-analyte respiratory panels, the US Food and Drug Administration (FDA) clarified on 9 September.

The agency added a new item to its questions and answers (Q&As) for laboratories and manufacturers of tests for SARS-CoV-2, the virus that causes COVID-19.

The new Q&A cites “the overlap in signs and symptoms between SARS-CoV-2 and other respiratory viral infections, including influenza.” Multi-analyte panels for respiratory infections, noted the agency, “are useful when multiple respiratory pathogens are circulating at the same time, as is expected with the upcoming flu season.” Being able to sort out COVID-19 from other seasonal respiratory illnesses such as Influenza A and B and respiratory syncytial virus (RSV) is both faster and a more efficient use of resources during the pandemic, said FDA.

Source: https://www.raps.org/news-and-articles/news-articles/2020/9/fda-clarifies-euas-for-covid-multi-analyte-respira