FDA Approves EUA Personal Use Rapid Result COVID-19 Tests

The FDA announces an emergency use authorization (EUA) COVID-19 All-In-One Test Kit manufactured by Lucira for at-home diagnostics on Nov. 17, 2020. Medical facilities, such as doctor’s offices, urgent care centers, hospitals, and emergency rooms, are also authorized to use this test in clinical settings in the United States.

Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVI-19.

Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health, added the agency looks forward to working with other test developers. They intend to encourage researchers to increase the availability of at-home test kits.

Lucira’s diagnostic test provides rapid results for the novel coronavirus SARS-CoV-2 that causes COVID-19. The test is authorized for those age 14 and older, whose doctor suspects the patient has the virus. Samples for children under 14 must be collected in a medical facility.

The test contains nasal swabs used to collect samples. Next, the swabs are swirled in the provided vial; it is then placed in the test unit. It takes 30 or less for the results, which are easily “read directly from the test unit’s light-up display.”

If the results are positive, the FDA directs the individual to contact their physician for additional care. The patient is further directed to self-isolate for 14 days.

Those whose test results are negative should follow up with their doctor. The reason is threefold; first, the test was ordered after the physician suspected the patient was infected. Second, medical facilities are required to report all test results to the local health department. Third, a negative result does not prevent the individual from a COVID infection.

Wearing a mask will prevent the transmission of the virus. Since the COVID infection has been detected in asymptomatic individuals who shed the contagion without foreknowledge, wearing a mask is vital.

Currently, the United States is in the middle of the third surge of COVID cases. As of November 23, 12.3 million cases have been reported since the pandemic hit the country. Two hundred fifty-seven thousand individuals died as a result of the virus.

Written by Cathy Milne-Ware

Sources:

FDA: FDA Authorizes First COVID-19 Test for Self-Testing at Home
FDA: Coronavirus (COVID-19) Update: November 10, 2020
CDC: Coronavirus Disease 2019 (COVID-19)

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