FDA approves emergency use for first at-home Covid-19 test kit

Covid-19 nasal swab test administered on patient.Lisa Maree Williams | Getty Images News | Getty ImagesThe U.S. Food and Drug Administration (FDA) has approved emergency use for the first Covid-19 test that can be conducted entirely at home.The agency cleared the single-use test, which provides results within 30 minutes, for use by anyone aged 14 and over if their health-care provider suspects they may have Covid-19.Produced by a privately held, California-based biotech company, Lucira Health, the kit is also eligible for use in hospitals, though patients under 14 must have their sample collected by a health-care provider.The FDA did not reveal the price of the test. The company’s website says the test is “intended to cost less than $50.””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,” FDA Commissioner Stephen Hahn said in a press release.”This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” he added.The nasal swab test involves swirling a patient’s self-collected sample swab in a vial, which is then placed in a test unit. Results are then made visible on the test’s light-up display within 30 minutes.The FDA noted that individuals who test positive should self-isolate and seek additional care from their health-care provider. Those who test negative and experience Covid-like symptoms should also follow up with their health-care provider, it added.

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