FDA grants Emergency Use Authorisation to Abott’s SARS-CoV-2, influenza and RSV test

The US Food and Drug Administration (FDA) has approved Abbott’s Alinity^™ m Resp-4-Plex molecular assay for emergency use. The assay can detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) in a single test. This is important because all four viruses have similar symptoms but require different treatment approaches.

The 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. The test uses the company’s Alinity m system – it uses Polymerase Chain Reaction (PCR) technology to amplify the viral RNA present in the sample before the detection phase.

The FDA’s Emergency Use Authorisation (EUA) includes an asymptomatic claim – ie, that the test can detect those without symptoms of COVID-19. A recent study indicates that > 60 percent of COVID-19 infections are asymptomatic; therefore, it is critical to have tests that can detect these cases. The EUA was also recently updated to include a pooling claim, which allows up to five samples to be tested at the same time.

The company stated that to help fight the pandemic, it has accelerated placements of the Alinity m system in hospital labs, academic centers and labs that are critical to patient care.

“Abbott has been developing and introducing tests that have been playing a critical role in fighting the pandemic. The need for a combination of testing methods in different settings has never been more clear,” said Andrea Wainer, executive vice president, Rapid and Molecular Diagnostics, Abbott. “This newest test will allow for fast and efficient diagnosis and triage of patients who present with respiratory symptoms so they can be given the right care.”

The Alinity^™ m Resp-4-Plex molecular assay is CE Marked and available in other countries outside the US. However, the availability of the Alinity m system and tests varies by geography, click here for more information.