FDA authorizes first home test that can detect flu and COVID-19

The Food and Drug Administration (FDA) authorized the first over-the-counter home test to detect and differentiate flu (commonly known as the flu) and COVID-19.

The test, created by California-based Lucira Health, works similarly to standard at-home COVID tests, with users twisting a self-taken nasal swab into a vial and placing it in a testing unit. After a 30-minute wait, the results show whether the person is positive or negative for influenza A, influenza B, or COVID-19.

“Today’s approval of the first OTC test that can detect influenza A and B, along with SARS-CoV-2, is an important milestone in increasing consumer access to diagnostic tests that can be performed entirely at home,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement Friday.

The announcement follows a surge in cases of COVID-19, flu and respiratory syncytial virus (RSV) towards the end of 2022, raising fears of a “tripledemic.”

The Centers for Disease Control and Prevention (CDC) reported this in November 5.8% of outpatient visits were due to respiratory disease with symptoms of fever, cough and sore throat – a 2.5% increase from baseline.

“The collective impact of COVID-19, influenza and RSV underscores the importance of diagnostic testing for respiratory viruses, and the FDA recognizes the benefits home testing can provide,” the FDA said in a statement.

The three respiratory viruses — RSV, COVID-19, and flu — share overlapping symptomsmaking it difficult for people determine what disease they have. But the new FDA test can differentiate between the flu and COVID.

According to the FDA, the test correctly identified 99.3% of negative and 90.1% of positive influenza A samples. It also identified 100% of negative and 88.3% of positive COVID-19 samples and 99.9% of negative influenza B samples. However, further testing is required for influenza B as there are not enough cases in practice.

The agency still encourages people to take precautions if they test positive for the flu or COVID-19 and to contact a medical provider for additional testing, even if the results are negative.

“The agency will continue to use its authorities to increase the number of appropriately accurate and easy-to-use home tests available to the public,” the FDA stated, “especially tests that detect these highly contagious respiratory viruses.”