Abbott (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the company's Alinity m Resp-4-Plex molecular assay to detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) in one test. This is an important tool because these viruses have similar symptoms but require different treatment approaches.
…The Alinity m Resp-4-Plex test can be conducted with one swab specimen (anterior nasal or nasopharyngeal) collected by a healthcare provider or an anterior nasal swab specimen self-collected at a healthcare location from individuals suspected by their provider of respiratory viral infection consistent with COVID-19. Test will run on Abbott's Alinity m system — the company's most advanced high-volume laboratory molecular instrument. Alinity m uses Polymerase Chain Reaction (PCR) technology, which is known for its high sensitivity in detecting infectious diseases.
ABT’s 4-in-1 test already has a CE Mark for ex-US use.
Abbott announced today it has received U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for over-the-counter, non-prescription, asymptomatic use of its BinaxNOW COVID-19 Ag Self Test for detection of COVID-19 infection. This new indication allows individuals with or without symptoms to have access to this test without a prescription. Abbott will begin shipping to major food, drug and mass merchandiser retailers in the coming weeks and expect the test to be available through some of their online store websites.
…Using the test will be simple, even for people who have never tested themselves. People will only need to perform a minimally invasive nasal swab (not the deep nasopharyngeal swab) and all materials required to perform the test (swab, test card, and reagent solution) will come in the box.
…The BinaxNOW Self Test is the same technology as the existing BinaxNOW test that has been available since August 2020 but is indicated by the FDA for serial asymptomatic testing, meaning that people should test themselves frequently.