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FDA Emergency Use Authorization for completely at-home COVID-19 test: press release (not widely available until next spring.)

2020-11-19

This press release from the FDA announces emergency use authorization for a completely at-home COVID-19 test using a nasal swab and a real-time loop mediated amplification reaction that takes about 30 minutes to complete. All you do is take a deep nasal swab and stick it in the container. The battery-powered device heats up a batch of chemicals; after 30 minutes, it lights up positive or negative.

The test is manufactured by Lucira Health in California, costs $50 for a single use, and claims it will be available nationwide in the spring. It is said to be at least 94% as sensitive as the gold standard RT-PCR test. The company also claims a 98% agreement with negative tests (otherwise known as specificity.) The test is intended for use on people with symptoms and it is available only by prescription.

The press release also notes that the “health care provider” (doctor, nurse practicioner, or physician assistant) is required to report the results to their local “relevant public health authorities.”

Lucira’s press release contains additional information, including the image I lifted from their web site, above. Live Science also has a post with similar information, and USAToday has a post as well. USAToday says the test will only be available at Sutter Health in northern California and Cleveland Clinic Florida in Miami-Dade until next spring. The Wall Street Journal also has a piece on the test, but it is certainly behind a paywall, so I won’t link to it.

FDA Commissioner Stephen Hahn said (per the FDA press release), “The FDA continues to demonstrate its unprecedented speed in response to the pandemic… Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing. ” Which sounds like something a publicist would say rather than an objective scientist. So you pays your money and you takes your chances.

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