FDA Clears First fully at-Home Covid-19 Test

Wall Street Journal:

U.S. regulator’s authorization is a long-awaited step for diagnostic testing, but initial supplies will be limited

The U.S. Food and Drug Administration has cleared the first Covid-19 test that people can take at home by themselves and get results without the help of a lab, a long-awaited step.

The single-use, disposable test from Lucira Health Inc. uses nasal swabs and can be self-administered by anyone with a doctor’s prescription ages 14 years or older. The test searches for the genetic material of the new coronavirus and can give results in 30 minutes or less, the company said.

Some Covid-19 tests have been previously authorized for at-home collection, but Lucira’s is the first that can be fully self-performed and provide results at home minutes later.

Public-health experts have been clamoring for fast, easy-to-use at-home Covid-19 testing, especially as the virus is spreading at increasing rates around the U.S. If made widely available and cost-effective, at-home testing could also become a valuable tool in helping people to safely return to schools and workplaces and beat back the pandemic before widespread vaccination.

The test, which the FDA cleared late Tuesday, is expected to be first available at Sutter Health in Northern California and at Cleveland Clinic Florida in Miami-Ft. Lauderdale, followed by a national rollout by early spring 2021.

Lucira said it expects its test to cost around $50 apiece.

“Being able to quickly determine if a person is infected or not has been a global problem,” said John Chou, a physician affiliated with Sutter Health who helped lead the study of the test. “We believe this highly mobile test can make a big difference by providing lab-quality results expeditiously and conveniently.”

Lucira said the test can correctly flag an infection 94.1% of the time and identify a negative result 98% of the time, when compared with a PCR test. If a sample has high levels of virus, the test is 100% sensitive, the company said.

Health authorities consider laboratory-based PCR tests to be the gold standard for assessing test accuracy. PCR tests also search for genetic material of the virus. They are nearly 100% accurate when administered and processed correctly, but they are expensive to conduct and can take days or longer to produce results. Antigen tests, which look for viral proteins, can identify the virus 84% to 97.6% of the time compared with PCR tests when used within five to seven days after a person develops symptoms, according to the U.S. Centers for Disease Control and Prevention.

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