The Alinity m Resp-4-Plex molecular assay will allow to identify and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus in one test
Abbott has received FDA EUA status for Alinity m Resp-4-Plex molecular assay. (Credit: Abbott)
Abbott has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Alinity m Resp-4-Plex molecular assay.
The Alinity m Resp-4-Plex molecular assay will help identify and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) in one test.
Abbott already secured CE mark approval for the Alinity m Resp-4-Plex molecular assay and supplying in countries outside the US.
The healthcare provider can use one swab specimen such as anterior nasal or nasopharyngeal to carry out the Alinity m Resp-4-Plex test.
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 can also be used to conduct the test.
Abbott’s Alinity m system, which is the company’s advanced high-volume laboratory molecular instrument, is used to conduct the test.
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 received EUA status for its Alinity m SARS-CoV-2 test to include an asymptomatic claim, thereby helping to identify Covid-19 in individuals who do not have symptoms.
Alinity m system is suitable to run assays, including SARS-CoV-2, HCV (hepatitis C), HBV (hepatitis B), HIV-1 (human immunodeficiency virus type 1), STI (CT/NG/TV/MG) and HR HPV.
Based on laboratory practice and workflow, the system has the potential to run up to 1,080 tests in 24 hours.
In January this year, Abbott secured CE mark approval for two new indications of its Panbio Covid-19 Ag rapid test device to identify the SARS-CoV-2 virus.