FDA Approves First At-Home COVID-19 Test

November 20, 2020

The first rapid coronavirus test that can be taken at home and deliver results in 30 minutes was cleared for emergency use by the U.S. Food and Drug Administration, paving the way for employers to consider its use.

Clinical trials showed patients were able to perform the Lucira self-test in about two minutes and have results within 30 minutes.  The test will cost about $50.

High accuracy important:  According to Lucira, the test accurately detected 94% of the infections found by a well-established PCR test.  It also correctly identified 98% of the healthy, uninfected people.

Availability questions:  It remains unclear how quickly Lucira can ramp up manufacturing and distribution.  Further, the test will be available by prescription only.

Outlook:  Until March 2021, the test will only be available on a limited basis in point-of-care settings and health care networks that prescribe.  By the second quarter of 2021, the company plans to enable people who think they might have COVID-19 to communicate online with a medical professional through a dedicated website to arrange a prescription and overnight delivery of the test kit.