A multiplex molecular test that can detect SARS-CoV-2 variants of concern and both influenza A and B with a single nasal swab received Emergency Use Authorization from the FDA. Although this test is only for use in point-of-care settings, it’s a step toward development of multiplex home tests, according to an agency press release.
The FDA approval notification explained that the Lucira COVID-19 and Flu Test is a single-use test intended for detection of either type of virus among patients suspected of having a respiratory viral infection consistent with COVID-19. It can be used for persons aged 2 years or older and is collected by a health care professional in a point-of-care setting operating under a clinical laboratory certificate. Negative test results should be confirmed with another FDA-authorized molecular test and combined with clinical observations, patient history, and epidemiological information for diagnosis, the agency said.
The test was developed in collaboration with the National Institutes of Health Independent Test Assessment Program, which was launched to accelerate regulatory review and availability of high-quality, accurate, and reliable over-the-counter COVID-19 tests to the public. Although the program is no longer reviewing COVID-19 tests, it is actively seeking multiplex point-of-care tests for accelerated review.
“This authorization demonstrates our continued commitment to expand the availability of multiplex tests for COVID-19 and flu,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the statement. “[W]e stand ready to authorize additional multi-analyte tests, including at-home tests, to meet current public health testing needs.”