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FDA Okays Take-Home COVID-19 Test for Over-the-Counter Sale

So-called antigen tests like these have been criticized as less accurate than slower PCR tests.

The Food and Drug Administration approved a take-home COVID-19 test for over-the-counter sale on Tuesday. According to the Mayo Clinic, antigen tests like these have a higher rate of false negatives than the PCR test, which delivers results slower. This antigen test—manufactured by Ellume—had 96 percent accuracy in a clinical study, the company said in a press release. Ellume expects to ship 100,000 tests daily beginning next month, according to the press release. The test will cost $30, according to Bloomberg News. “We are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes,” FDA Commissioner Stephen Hahn said in a statement.