FDA Authorizes Test for SARS-Cov-2, Flu, RSV Detection

Healthcare technology company Abbott has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for an assay which can differentiate SARS-CoV-2, influenza type A and B, and respiratory synctical virus (RSV) in a single test.

The Alinity m Resp-4-Plex molecular assay, conducted with a single anterior nasal or nasopharyngeal swab at a healthcare clinic, will be made available to patients suspected by their providers to have a respiratory viral infection consistent with COVID-19.

The capability of the test allows caregivers to conduct urgent-speed testing of patients with respiratory infection symptoms akin to any of the 4 diseases. What’s more, its simultaneous detected of multiple respiratory viruses allows for eased collection resources, a crucial priority in pandemic virus monitoring.

The EUA allows for pooling, meaning up to 5 samples can be tested by 1 device at a time.

Previously, the Alinity m testing system has been regulated for use in detecting SARS-CoV-2, hepatitis B and C viruses, HIV-1, sexually transmitted infections, and human papillomavirus (HPV).

As Andrea Wainer, executive vice president of Rapid and Molecular Diagnostics at Abbott, noted in a statement, this latest indication is another contribution from the company in frontline testing during the COVID-19 pandemic.

The need for a combination of testing methods in different settings has never been more clear," Wainer said. "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."