FDA Authorizes At-Home Test Kit that Doesn't Require Prescription

Courtesy Lucira Health

The Food and Drug Administration on Wednesday authorized a Covid-19 home collection kit that does not require a prescription, the agency announced.

Posted: Dec 9, 2020 9:33 PM

NBC News - The Food and Drug Administration on Wednesday authorized a Covid-19 home collection kit that does not require a prescription, the agency announced.

LabCorp’s home collection kit must be sent away for analysis, but a top FDA official said that it removes a step. There are other collect-at-home kits, but this is the first authorized for sale over-the-counter at stores or online, the agency said.

The LabCorp Pixel COVID-19 Test Home Collection Kit involves a person collecting a nasal swab and then sending it in. If positive, users get a call from a health care provider. Negative results are emailed or available online, the FDA said.

Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics, said in a statement that the authorization could help more people get tested and reduce the spread of the virus.

The FDA last month granted emergency authorization to a test that is taken at home and gives results at home, but that needs a prescription and is for people who health providers suspect have Covid-19.

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