Abbott receives FDA EUA for lab PCR assay that detects, differentiates SARS-COV-2, Flu A, Flu B, and RSV in single test

March 5, 2021  –  Abbott (Abbott Park, IL) announced U.S. Food and Drug Administration (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.

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.

Tests will run on Abbott’s Alinity m system, which uses Polymerase Chain Reaction (PCR) technology. 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.

Abbott also announced that the EUA for the company’s Alinity m SARS-CoV-2 test was updated to include an asymptomatic claim – detecting COVID-19 in individuals who do not have symptoms.

A recent study found that more than 60% of COVID-19 infections present as asymptomatic cases, which is why it’s critical to catch those cases before they spread.

With the recent update to the Alinity m SARS-CoV-2 test EUA, the assay can now be used to detect individuals who are infected with SARS-CoV-2, but do not have symptoms or other reason to suspect COVID-19 infection.

The Alinity m SARS-CoV-2 test EUA was also updated to include a pooling claim, which allows up to five samples to be tested at the same time. The updated Alinity m SARS-CoV-2 test, Alinity m Resp-4-Plex assay, and Abbott’s existing testing technologies will now all be available to support front-line healthcare workers.

This test is CE Marked and available in countries outside the U.S.

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