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Abbott Gets FDA EUA for Test That Detects Coronavirus, Three Other Respiratory Infections

NEW YORK — Abbott said on Friday that it has received Emergency Use Authorization from the US Food and Drug Administration for a PCR-based assay that can detect and differentiate SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus.

The newly authorized Alinity m Resp-4-Plex assay, which is also CE marked, uses a single anterior nasal or nasopharyngeal swab sample collected by a healthcare provider or self-collected at a healthcare facility, according to Abbott. It runs on the company's Alinity m system.

Abbott also said that the previously granted EUA for its Alinity m SARS-CoV-2 test has been updated to include its use with asymptomatic individuals, as well as with pooled samples.

That test was first authorized by the FDA in December for detecting SARS-CoV-2 nucleic acid in nasal, nasopharyngeal, and oropharyngeal swabs, as well as bronchoalveolar lavage specimens, collected from individuals suspected of having COVID-19.

According to Abbott Park, Illinois-based Abbott, that EUA has now been expanded to allow the test's use with people not showing symptoms of infection and with up to five samples at a time.