By Sarah Roebuck
EMS1
WASHINGTON — The U.S. Food and Drug Administration has issued an emergency use authorization for the first over-the-counter at-home influenza diagnostic test.
The test can differentiate and detect influenza A and B, according to the FDA. The Lucira COVID-19 & Flu Home Test by Pfizer is a single-use at-home test that provides results collected from nasal swab samples in about 30 minutes.
The test is available for purchase without the need for a prescription and can be fully administered at home. It utilizes nasal swab samples that individuals who are 14 years of age or older can collect themselves, or that can be collected by an adult for individuals who are 2 years of age or older, the FDA says.
In symptomatic individuals, the Lucira COVID-19 & Flu Home Test accurately detected 99.3% of negative and 90% of positive Influenza A samples, 100% of negative and 88.3% of positive COVID-19 samples and 99.9% of negative Influenza B samples, the FDA states. Due to a current lack of Influenza B cases for clinical studies, the test’s effectiveness for detecting Influenza B was confirmed using artificial samples. The EUA mandates Lucira gather more samples to evaluate the test’s real-world efficacy in detecting Influenza B.
The test is available for purchase on Amazon and at Walgreens.