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The test is for patients to use at home, with a prescription, to detect both COVID-19 and influenza A and B.
FDA authorized the first diagnostic test for at-home collection of patient samples to detect both COVID-19 and influenza A and B.
Quest Diagnostics’s RC COVID-19 +Flu RT-PCR Test is available via prescription with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu, FDA said in a press release.
The test is for patients who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by their healthcare provider. With the prescription, patients can collect a sample at home and ship it to a Quest Diagnostics lab for analysis.
“Today’s authorization for a COVID-19 plus flu test using samples collected at home is a significant step toward FDA’s nationwide response to COVID-19. 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” said FDA Commissioner Stephen M. Hahn, MD.
“With just one swab or sample, combination tests that are authorized for use with home-collected samples can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”
FDA also recently granted an EUA for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit (Lucira Health) is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19, the agency said in a press release.
As of December 1, 295 COVID-19 tests are authorized by FDA under Emergency Use Authorization (EUA). These include 227 molecular tests, 61 antibody tests, and 7 antigen tests.