The company also received updated EUA for asymptomatic usage of its Alinity m SARS-CoV-2 assay
Abbott headquarters. (Credit: Abbott.)
US-based health technology firm Abbott has received the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) for its Alinity m Resp-4-Plex molecular assay.
Alinity m Resp-4-Plex is designed to detect and differentiate four viruses including SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) in a single test.
The CE Marked Alinity m Resp-4-Plex test runs on the company’s high-volume laboratory molecular instrument Alinity m system using a single anterior nasal or nasopharyngeal swab specimen.
The test uses a sample collected by a healthcare provider or self-collected at a healthcare location from individuals suspected of respiratory viral infection by their provider.
Alinity m system leverages Polymerase Chain Reaction (PCR) technology, which offers high sensitivity in detecting infectious diseases.
Abbott said that its Alinity m Resp-4-Plex assay is a critical tool in detecting the four widespread respiratory viruses, have similar symptoms.
Abbott rapid and molecular diagnostics executive vice president Andrea Wainer said: “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. 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.”
Abbott has also secured an expanded EUA from the US FDA for its Alinity m SARS-CoV-2 test, which was originally authorised in May 2020.
The updated EUA allows the use of the Alinity m SARS-CoV-2 test in detecting individuals infected with SARS-CoV-2, but do not have symptoms of Covid-19 infection.
According to a recent study, more than 60% of Covid-19 infections are asymptomatic cases, and the expanded EUA is critical to test those cases before they spread the virus.
The EUA was also expanded to include sample pooling, which allows the testing of up to five samples simultaneously.
Abbott said that its updated Alinity m SARS-CoV-2 test, Alinity m Resp-4-Plex assay, and existing testing technologies will support front-line healthcare workers.