U.S. Approves First Self-Testing Kit for Detecting Covid-19

The U.S. gave the greenlight for the first Covid-19 diagnostic kit for self-testing at home, adding an additional tool to battle the pandemic as nationwide testing capabilities come under more strain.

The Food and Drug Administration issued an emergency use authorization to Lucira Health Inc.’s rapid-result All-In-One Test Kit, according to a statement from the government agency Tuesday.

While some Covid-19 tests allow people to provide samples from home, this is the first that can be fully self-administered and provide results at home in 30 minutes or less. The approval comes at a time when the country — which has the the world’s largest number of total cases, at more than 11 million — is fighting a fierce resurgence of infections.

“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen Hahn in the statement.

It could also help take some strain off testing labs that are being overwhelmed by demand. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said Tuesday that if communities could have carried out widespread testing, it could have helped slow transmission before it took off explosively.

Complete self-testing isn’t widely adopted in the world as it runs the risks of introducing human error and false results, and cases may go unreported to the officials.

The Lucira test is currently authorized for prescription use only, and the FDA said health-care providers are required to report all results to the government.

The Lucira test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. The results can be read directly from the test unit’s light-up display. In addition to home use, the product is also authorized for use in doctor’s offices, hospitals and emergency rooms.

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