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COVID-19 Point-of-Care Diagnostic Granted Emergency Use Authorization

And, FDA warns consumers about unauthorized fraudulent COVID-19 test kits marketed as home test kits

MONDAY, March 23, 2020 (HealthDay News) -- The Cepheid Xpert Xpress SARS-CoV-2 test received the first emergency use authorization for a point-of-care diagnostic for the novel coronavirus (COVID-19), the U.S. Food and Drug Administration announced Saturday.

The emergency use authorization is intended for high- and moderate-complexity CLIA-certified laboratories and certain patient care settings. The company plans to make the tests available by March 30.

The test provides results within hours rather than days like the tests currently being used, according to U.S. Secretary of Health and Human Services Alex Azar. Patients will receive their results in hospitals, urgent care centers, and emergency rooms, rather than waiting for samples to be sent to the laboratory. "With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them," Azar said in a statement.

In a separate FDA release on Friday afternoon, the agency warned consumers about unauthorized fraudulent COVID-19 test kits that are marketed as home test kits. "We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19," the agency wrote in the statement. "The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space."

The agency has already issued warning letters to seven companies that were selling and promoting fraudulent items, including teas, essential oils, tinctures, and colloidal silver, that claim to treat or prevent COVID-19. The FDA is also enhancing enforcement at ports of entry, including International Mail Facilities, to prevent entry of fraudulent products from outside the country. If you are aware of fraudulent test kits for COVID-19, the FDA requests that you report them to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.

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