FDA Permits Over-the-Counter Test for COVID-19 and Influenza

The FDA granted an emergency use authorization (EUA) on February 24 for the use of OTC at-home tests that can detect both SARS-CoV-2, or COVID-19, and influenza A and B, known as the flu.

The Lucira COVID-19 & Flu OTC at-home test can identify both viruses and distinguish between the two through nasal swab samples in about 30 minutes.

The Lucira test kit is a single-use kit that individuals who feel sick can use. It will be available for purchase without a prescription and can be used by anyone 14 years or older. If under the age of 14, adults can collect nasal swab samples for them. Similar to at-home COVID-19 test kits commonly used in the past, the kit requires whirling the nasal sample swab in a provided vial. In approximately 30 minutes, the kit will show whether a person is positive or negative for Influenza A, Influenza B, or COVID-19.

"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," reported the director of the FDA’s Center for Devices and Radiological Health Jeff Shuren, M.D., J.D.

"The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs. We remain committed to working with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them."

Once given the result, individuals can provide the information to their primary healthcare provider for public health reporting and to get treated, if necessary. The Lucira COVID-19 & Flu Home Test accurately detected 99.3% of negative and 90.1% positive Influenza A samples. It also discerned 100% of negative and 88.3% of positive COVID-19 samples and 99.9% of negative Influenza B samples. The EUA asks Lucira to resume gathering samples to study the test's capacity to catch Influenza B in real-world settings, as there are not enough cases of Influenza B spreading to incorporate in a clinical study.

However, validation demonstrated that the test could identify the virus in contrived samples. Like every other rapid diagnostic test kit, there is a chance of false positive and negative results; thus, those who test positive for either virus should be careful and avoid spreading it to others. Individuals who test negative yet still exhibit symptoms should follow up with a medical professional.

The FDA acknowledges the advantages of at-home kits for respiratory viruses, and the combined effects of COVID-19, the flu, and RSV highlight the significance of diagnostic tests for respiratory viruses. They will resume using authority to expand the number of suitable, proper, and simple at-home kits available to the general public, specifically those that can catch these highly infectious respiratory viruses.

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