The US Food and Drug Administration (FDA) has granted an emergency use authorisation (EUA) for the over-the-counter (OTC) use of Lucira COVID-19 & Flu Test to detect influenza A and B and SARS-CoV-2 virus.
Lucira Health, a US-based medical technology company, has designed the at-home molecular diagnostic test to differentiate and detect flu and the COVID-19-causing viruses.
The Lucira COVID-19 & Flu Test is a single-use at-home test kit that is said to deliver results from self-collected nasal swab samples in about half an hour. It is a one-time usage test for anyone exhibiting symptoms that are typical of a COVID-19-related respiratory tract infection.
The OTC clearance will enable customers to purchase the test without a prescription. It can be performed entirely at home using nasal swab samples that people 14 years of age and older self-collect, or that adults collect for people two years of age and older.
According to the FDA, the sample swab is swirled in a vial that is put inside the test unit to conduct the test.
The test unit will indicate if a person is positive or negative for COVID-19, Influenza A, or Influenza B.
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.”
The Lucira COVID-19 & Flu Test successfully detected 100% of negative and 88.3% of positive COVID-19 samples, 99.9% of negative Influenza B samples, and 99.3% of negative and 90.1% of positive Influenza A samples, the US health regulator claimed.
