FDA Authorizes Quest Diagnostics SARS-CoV-2/Flu Test With Self-Collection Kit for Emergency Use

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The US Food and Drug Administration on Friday evening granted Emergency Use Authorization for the first time to a diagnostic test for at-home, self-collection of patient samples for the detection of SARS-CoV-2 and influenza A/B.

The FDA authorized Quest Diagnostic’s RC COVID-19  +Flu RT-PCR test for prescription use with the company’s Self-Collection Kit for COVID-19 +Flu by individuals suspected of having a respiratory infection consistent with the coronavirus. If a healthcare provider determines that self-collection is appropriate for use with the test and self-collection kit, a patient can collect the sample at home and ship it to a Quest laboratory for analysis.

The test is for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, and/or influenza B virus in nasal swab specimens, the FDA said. Testing is limited to labs designated by Quest that are CLIA certified and can perform high-complexity tests.

“With the authorization of this test, the FDA is helping to address the ongoing fight against COVID-19 while in the middle of the flu season, which is important for many, including the most vulnerable of Americans,” FDA Commissioner Stephen Hahn said in a statement.