FDA Authorizes Marketing of At-Home Test for Covid, Flu

By Connor Hart

The Food and Drug Administration on Monday granted marketing authorization for an over-the-counter test for both Covid-19 and influenza.

The Rapid Check COVID-19/Flu A&B Antigen Test doesn't require a prescription, allowing individuals experiencing respiratory symptoms to receive at-home results in approximately 15 minutes for Covid and flu. It was developed by Healgen Scientific, a Houston-based medical-equipment manufacturer.

Using a nasal swab, the test can detect proteins from both SARS-CoV-2, which is the virus that causes Covid, and influenza A and B, which are the viruses that cause the flu, the FDA said. It added that this is the first over-the-counter test that can detect influenza to be granted marketing authorization using a traditional premarket review pathway, which enables the test to be marketed in the absence of an applicable emergency use declaration.

The test can be used by individuals ages 14 and older taking and testing their own sample, or by individuals ages 2 and older with a sample taken and tested by an adult.

Data reviewed by the FDA showed the test correctly identified 99% of negative and 92% of positive Covid samples, 99.9% of negative Flu A and B samples, and 92.5% and 90.5% of positive Flu A and Flu B samples, respectively. The agency warned that there is a risk of false negative test results, as there is with all rapid antigen tests.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

October 07, 2024 20:05 ET (00:05 GMT)

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