FDA authorizes oral rinse-and-spit test for COVID-19

The FDA has expanded an emergency authorization of a COVID-19 diagnostic to allow it to test samples gathered by rinsing a person’s mouth with simple saline.

By swishing and gargling a small amount of solution for 30 seconds and then spitting it into a funnel and vial, the test both eliminates the need for a nasal swab and assists people who may have trouble providing sufficient amounts of saliva for a direct test. 

In addition, the samples can be stored for up to 72 hours at room temperature before processing. The prescription-only OraRisk molecular diagnostic test, developed by Access Genetics and its subsidiary OralDNA Labs, is designed to be administered by a healthcare professional.

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The same test was previously granted a green light by the agency in mid-July for use with nasopharyngeal, nasal and oral swabs.

"Oral rinse collection will be a game-changer for COVID testing," OralDNA CEO George Hoedeman said in a statement. "A 30-second convenient collection without a nasal swab will improve patient comfort, minimize exposure risk to frontline healthcare professionals, shorten collection time, and avoid supply chain bottlenecks.”