FDA Authorizes First At-Home COVID-19 Testing Kit

Symptomatic patients can now collect their own samples at home

covid-19 test
At-home testing will reduce healthcare workers' exposure to symptomatic patients.
Alessio Coser/Getty Images

The United States Food and Drug Administration has authorized the first at-home COVID-19 tests, produced by diagnostics company LabCorp.

The new test will allow people to swab their nose to collect a fluid sample, which will then be sent to a lab for testing. The self-administered test would involve swirling a cotton swab just inside the nostril, which an analysis done by UnitedHealth Group and the Gates Foundation found to be just as accurate as the more invasive swabbing methods practiced by clinicians, in which a swab is stuck very deep into a patient’s nose, to the point where the back of the nose meets the throat.

“We worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site,” said FDA Commissioner Stephen M. Hahn, M.D. in a statement. “With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”

The at-home sampling enabled by these new tests eliminates the need for a clinician to perform the the test, reducing healthcare professionals’ contact with symptomatic patients, while also reducing the demand for protective equipment in short supply.

The LabCorp test is the first of many attempted at-home tests created by various biotech companies to secure necessary FDA authorization. The test, like other COVID-19 tests currently on the market, was authorized under the FDA’s emergency use rules, meaning it hasn’t gone through the standard approval process required in non-emergency circumstances.

The test will cost $119, and first access will be given to healthcare workers and first-responders.

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