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FDA Authorizes First At-Home COVID-19/Flu Combination Test

December 9, 2020

The FDA has granted Emergency Use Authorization for Quest Diagnostic’s RC COVID-19 and Flu RT-PCR test, the first coronavirus/flu combo diagnostic cleared by the agency for at-home self-collection of samples.

The test is usable with a prescription and enables patients to collect their own samples and ship them to a Quest Diagnostics laboratory from home. The company said it typically provides patients with test results in two to three days and can deliver results for prioritized patients in two days.

“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,” said FDA Commissioner Stephen Hahn.

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