First FDA Approved At-Home COVID-19 Test Kit

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Day 247: Stay Safe Minnesota

On Tuesday, FDA approved emergency use of first at-home COVID-19 rapid testing kit that delivers results in 30 minutes.

On Tuesday November 17, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first Lucira Health’s COVID-19 diagnostic test for self-testing at home and that provides rapid results.

The Lucira Health Fact Sheet states: “The Lucira COVID-19 All-In-One Test Kit is a single use test kit intended to detect active infection with the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is for prescription home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19, and for use in point of care settings for all ages, limited to healthcare provider collection in individuals aged 13 and under.”

“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission. Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

FDA Commissioner Stephen M. Hahn (source: FDA News Release)

The Lucira COVID-19 All-In-One Molecular Single Use Test Kit is expected to cost about $50 and can be obtained ONLY by a prescription from a health care provider.

How the Test Works?

For COVID-19 testing, a small nasal swab is sample is self-collected in a vial which is then placed in a hand-held test unit, can provide results in 30 minutes as positive or negative in a battery-powered unit’s display.

“The test uses technology similar to genetic laboratory-based tests that are the standard tool for COVID-19 screening. That’s different than most rapid tests currently used in the U.S., which look for viral proteins called antigens — not the virus itself,” writes Associated Press’s Mathew Perrone in the Star Tribune.

Screenshot from Lucira Health

“People taking the battery-powered test must swirl a swab in both of their nostrils, then dip and stir the swab into a vial of chemicals. That vial is then plugged into a test cartridge that processes the sample. Within half an hour, the test cartridge will light up as “positive” or “negative.” Federal guidelines note that people taking the test should report the results to their health care providers, who must then inform public health authorities to help track the virus’s spread.”

Katherine J. Wu from the New York Times

There are about two dozen companies that are reportedly working for months to develop the first, rapid home-based test for COVID-19. However, only a few could meet FDA’s strict requirement for approval primarily meeting concerns that ‘whether people without any medical training can accurately screen themselves and interpret the results‘.

“I think increased testing closer to patients, including in the home, is the way of the future. But there are considerations that have to be addressed to make sure that this is done in a safe and effective way.”

Dr. Robin Patel of the Mayo Clinic, in an interview before the announcement was made (source: Star Tribune)

“The FDA has only ever approved one home test for an infectious disease — an HIV test. And even commonplace over-the-counter tests— such as home pregnancy kits — were subject to years of scrutiny before FDA allowed their use in the 1970s,” writes Perrone in the Tribune.

Coronavirus Pandemic Watch

According to the MDH latest tally (as of Nov 29, 11 a.m.) the confirmed COVID-19 cases in Minnesota are 312,969 (out of 4,219,424 tested) with 3,578 deaths. According to Johns Hopkins database (as of Nov 29, 1:25 p.m.) there are 13,324,717 confirmed covid19 infection with 266,534 deaths. Globally the covid19 virus has infected 62,555,683 with 1,457,098 deaths.