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FDA Grants Emergency Clearance for Home Covid-19 Test

Lucira test

Lucira All-In-One Test Kit (Lucira Health Inc.)

18 Nov. 2020. The Food and Drug Administration gave an emergency authorization for a self-collected Covid-19 diagnostic test, the first such test for home use. In a related announcement, FDA pledged to provide more information on scientific reviews and decision-making about its emergency use authorizations for Covid-19 drugs and biologics, including vaccines.

FDA’s action authorizes the Covid-19 diagnostic test made by Lucira Health Inc. in Emeryville, California. The Lucira All-In-One Test Kit detects the presence of SARS-CoV-2 viruses causing Covid-19 infections in adults and adolescents age 14 and over, with a doctor’s prescription. The test uses mid-nose nasal swab samples, rather than nasopharyngeal samples from deep inside the nose and throat requiring a clinician to collect. As a result, the Lucira test can be conducted at home, although FDA’s authorization covers point-of-care diagnostics in a clinic.

The All-In-One Test Kit is a single-use test that includes a nasal swab. The instructions recommend rotating the swab five times in each nostril to collect a sufficient specimen. The user then inserts the swab in a vial attached to a container with reagents that interact with the nasal swab specimen. After 30 minutes, lights on the reagent container indicate a positive or negative result for SARS-CoV-2 virus in the specimen, or an invalid test.

Individuals are instructed to report test results to their physicians. A separate fact sheet for health care providers recommends follow-up guidance for patients, as well as consideration of false positive and negative results in the context of patients’ recent activities, exposure, and symptoms. And the fact sheet advises providers to follow standard reporting guidelines for test results issued by local health authorities.

“A test that can be fully administered entirely outside of a lab or health care setting has always been a major priority for the FDA to address the pandemic,” says Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, in an agency statement. “Now, more Americans who may have Covid-19 will be able to take immediate action, based on their results, to protect themselves and those around them.”

Lucira says its All-In-One Test Kits will be available first through the Sutter Health system in northern California and Cleveland Clinic in south Florida where assessments of the device are conducted. Nationwide availability is planned for spring of 2021. The company says the test kit will be priced at $50.00.

Stephen Hahn, the FDA commissioner, issued a separate statement yesterday outlining disclosure practices for emergency use authorizations, or EUAs, on vaccines, and other Covid-19 drugs and biologics. Hahn says FDA will begin posting scientific review documents and other information permitted by law supporting new EUAs, as well as revisions or revocations, once agency reviews are complete.

Hahn says the disclosure policy is aimed at building trust in FDA’s work, when new vaccines and therapies are expected to be available soon for the public. “In particular,” Hahn notes, “we recognize that disclosing information from the scientific review documents supporting the issuance, revision, or revocation of EUAs for drugs and biological products, including vaccines, will contribute to the public’s confidence in the agency’s rigorous review of scientific data and the appropriate use of authorized products.”

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