FDA

FDA Authorizes First At-Home Combination Diagnostic Test for COVID-19 and Flu

By MedTech Intelligence Staff
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FDA

Patients will be able to collect their own samples and ship it to a Quest Diagnostics lab for analysis.

Last week Quest Diagnostics received FDA authorization for the first at-home diagnostic test that can detect both COVID-19 and influenza A and B. The RC COVID-19 +Flu RT-PCR Test is available with a prescription for use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by someone who is suspected to have a respiratory viral infection consistent with COVID-19. If a healthcare provider determines that home collection is appropriate, the patient collects the sample at home using the self-collection kit and sends it to a Quest Diagnostics lab for analysis.

“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,” stated FDA Commissioner Stephen Hahn, M.D., in an agency news release. “This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”

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