ABBOTT PARK, Ill.—Abbott Laboratories reported today that the FDA has issued an 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). This test is CE Marked, and available in countries outside the US as well.
The Resp-4-Plex test runs on Abbott’s Alinity m system, which uses polymerase chain reaction (PCR) technology known for its high sensitivity in detecting infectious diseases. The 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 from individuals who are suspected of respiratory viral infection consistent with COVID-19.
“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 of Rapid and Molecular Diagnostics at 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 system provides automation and on-demand access, which means that an urgent test can be run at any time. This flexibility allows for the testing of multiple diseases while still producing fast results in high volumes. This assay’s ability to detect and differentiate these viruses simultaneously with one swab will also ease the resource strain on collection devices, which have been in high demand throughout the COVID-19 pandemic.
Abbott has also announced that the EUA for the company’s Alinity m SARS-CoV-2 test has been updated to include an asymptomatic claim — detecting COVID-19 in individuals who do not have symptoms. With the recent update to the EUA for the SARS-CoV-2 test, the assay can now be used to detect individuals who are infected with SARS-CoV-2, but do not have symptoms or other reasons to suspect COVID-19 infection. The SARS-CoV-2 test EUA was also updated to include a pooling claim, which allows up to five samples to be tested simultaneously.