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.
This is not a point-of-care test (i.e. it requires that samples be sent to a lab), but it’s nevertheless an opening for increased diagnosis of RSV.
ABT’s 4-in-1 test already has a CE Mark for ex-US use.
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