
Abbott’s received FDA EUA for laboratory PCR assay that detects and differentiates SARS-CoV-2, Flu A, Flu B and RSV
On Mar. 5, 2021, Abbott announced the U.S. Food and Drug Administration’s (FDA) 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) in one test.
This is an important tool because these viruses have similar symptoms but require different treatment approaches. This test was CE Marked and available in countries outside the U.S.
The Alinity m 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 at a healthcare location from individuals suspected by their provider of respiratory viral infection consistent with COVID-19.
Test will run on Abbott’s Alinity m system — the company’s most advanced high-volume laboratory molecular instrument. Alinity m uses Polymerase Chain Reaction (PCR) technology, which is known for its high sensitivity in detecting infectious diseases. To help fight the pandemic, Abbott has accelerated placements of the Alinity m system in hospital labs, academic centers and labs that are critical to patient care.
The Alinity m Resp-4-Plex assay will be a critical tool in detecting these four prevalent respiratory viruses. The advanced technology of the Alinity m system provides automation and on-demand access, meaning an urgent test can be run at any time. This flexibility and efficiency allow 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 only one swab will also ease the resource strain on collection devices, which have been in high demand throughout the COVID-19 pandemic.
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Source: Abbott
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