The U.S. Food and Drug Administration (FDA) on Friday issued an emergency use authorization (EUA) for the Lucira COVID-19 & Flu Test -- the first over the counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B and SARS-CoV-2.
The single-use at-home test kit, developed by Lucira Health, provides results from self-collected nasal swab samples in roughly 30 minutes.
“Today’s authorization … is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
The test is for individuals with signs and symptoms consistent with a respiratory tract infection, including COVID-19. It can be purchased without a prescription and performed from start to finish at home using nasal swab samples self-collected by individuals ages 14 years and older or collected by an adult for individuals 2 years of age or older.
The test works by swirling the sample swab in a vial that is placed in the test unit. In 30 minutes or less, the test unit will display the results that show whether a person is positive or negative for influenza A, influenza B, or COVID-19.
In individuals with symptoms, the Lucira COVID-19 & Flu Test correctly identified 99.3% of negative and 90.1% 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 said.
Since there are currently not enough cases of influenza B circulating to include in a clinical study, validation confirmed that the test can identify the virus in contrived specimens, and the EUA requires Lucira to continue to collect samples to study the test’s ability to detect influenza B in real-world settings.
On Friday, the FDA also issued an emergency use authorization (EUA) for the GenBody COVID-19 Ag Home Test, which is manufactured by GenBody; on Wednesday, the agency issued an EUA for the COVI-Go-SARS-CoV-2 Ag Self Test manufactured by Mologic.
Validation data to support the EUAs of these two tests were gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH.
Both tests can be used for serial testing for symptomatic people within the first five days of symptom onset or for people who do not have symptoms.
The GenBody COVID-19 Ag Home Test shows results in 15 minutes, and the COVI-Go-SARS-CoV-2 Ag Self Test shows results in 20 minutes.
