COVID-19 self test with negative result

FDA Approves 1st At-Home Test for Both Flu, COVID

COVID-19 self test with negative result

A COVID-19 instant test on Jan. 8, 2022. This test results were negative denoted by the line at the C. (Ray Saint Germain / Bay City News)

By Eli Walsh
Bay City News Foundation

Federal regulators authorized the first over-the-counter, at-home test Friday that can detect both the flu and COVID-19.

The U.S. Food and Drug Administration issued an emergency use authorization for the Lucira COVID and flu test, which provides test results from a nasal swab in roughly 30 minutes, according to the FDA.

The test is similar to those for COVID and can be self-administered by anyone ages 14 and older or administered by an adult for children between ages 2 and 13.

According to the FDA, the Lucira test gave correct results for roughly 99% of both negative influenza A and B samples, 100% of negative COVID samples, 90% of positive influenza A samples and 88% of positive COVID samples.

All trial samples were taken from people with symptoms, FDA officials said.

“Today’s authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” said Dr. Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health.

>>>Read: County Offering 4 At-Home COVID-19 Tests for Free Via Mail-Order Program

The authorization requires Lucira to continue collecting test samples to confirm its ability to correctly report positive and negative influenza B samples, as there are not enough cases of that flu strain for a clinical study.

The FDA approved a separate non-prescription COVID and flu test, manufactured by Labcorp, last spring.

That test allowed users to send a nasal swab to Labcorp’s laboratories for analysis, but did not provide at-home results.

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