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FDA Gives Approval To First COVID-19 Self Testing Kit

On Tuesday, U.S. Food and Drug Administration gave approval to the first COVID-19 self testing kit for home use. The test could provide the results within 30 minutes.

FDA Commissioner Stephen Hahn said: “While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home.”

The single-use test, made by Lucira Health, has been given emergency use authorization for home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their health care provider, the FDA said.

The kit can also be used at hospitals and point-of-care settings but samples should be collected by a healthcare provider if the individuals who are tested are younger than 14 years, the health regulator said.

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