FDA grants at-home test to detect both flue and COVID-19 viruses

The U.S. Food and Drug Administration (FDA) on Friday granted an Emergency Use Authorization (EUA) for the first over-the-counter, home diagnostic test to protect against influenza A and B, commonly known as influenza, and SARS-CoV-2, which causes COVID-19 to distinguish and prove.

Lucira COVID-19 & The flu home test is a single-use home test kit that provides results from home-collected nasal swab samples in approximately 30 minutes, the drug regulator said.

According to the FDA, Lucira COVID-19 & The flu home test is a single-use test for people with signs and symptoms consistent with a respiratory infection, including COVID-19. The test can be purchased without a prescription and can be carried out completely at home with a self-taken nasal swab from the age of 14 or by an adult from the age of 2.

The first and only test of its kind to test for Covid and Flu at home or point-of-care, the Lucira COVID-19 & Flu Test is not a rapid antigen test. It is a molecular test that is 99% accurate when compared to sensitive lab-based PCR tests.

The test consists in rotating the swab in a bottle placed in the test unit. In 30 minutes or less, the testing device displays results indicating whether the person is positive or negative for each of the following: influenza A, influenza B, and COVID-19. Individuals should report any results obtained to their physician for public health reporting and appropriate medical care.

For people with Lucir symptoms of COVID-19 & Correctly identified flu home test 99.3% negative specimens and 90.1% positive specimens for influenza A, 100% negative specimens and 88.3% positive specimens for COVID-19 and 99.9% negative specimens for influenza B, the FDA said.

As with all rapid diagnostic tests, there is a risk of false positive and false negative results. People who have tested positive for the flu or COVID-19 should take appropriate precautions to avoid spreading the virus and should seek further help from their doctor or healthcare professional as further testing may be required, FDA suggested.

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