Lucira Health has received US Food and Drug Administration (FDA) emergency use authorization (EUA) for its COVID-19 & Flu over-the-counter (OTC) at-home test.
The new single-use at-home test kit has been designed to detect and differentiate influenza A and B, which are commonly known as the flu, as well as the SARS-CoV-2 virus.
It uses self-collected nasal swab samples and provides test results in approximately 30 minutes.
The Lucira COVID-19 & Flu Home Test is indicated for use by people who have signs and symptoms that are consistent with a respiratory tract infection, including Covid-19.
It does not require a doctor’s prescription.
According to the FDA, the test correctly identified 90.1% of positive and 99.3% of negative influenza A samples, 99.9% of negative Influenza B samples, and 88.3% of positive and 100% of negative Covid-19 samples in symptomatic individuals.
The regulatory agency stated that the EUA requires Lucira to continue collecting samples to evaluate the ability of the test to detect influenza B in real-world settings.
FDA Center for Devices and Radiological Health director Jeff Shuren said: “Today’s authorisation of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home.
“The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs.
“We remain committed to working with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them.”