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FDA Issues Emergency Use Authorization for PerkinElmer COVID-19/Flu Test

PerkinElmer said on Thursday that the US Food and Drug Administration has granted Emergency Use Authorization for the firm's assay to detect SARS-CoV-2 and the flu.


The PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 allows labs to qualitatively detect and differentiate the coronavirus, influenza A, influenza B, and respiratory syncytial virus, the Waltham, Massachusetts-based company said. Nasopharyngeal swabs, anterior nasal swabs, and mid-turbinate swabs can be used with the test, which received the CE mark a year ago.


The test can be used only in CLIA-certified labs that can perform high-complexity tests.


"The new test will help to alleviate confusion arising from similar symptoms caused by these infections and reduce further strain on the healthcare system during a pandemic," Arvind Kothandaraman, PerkinElmer's managing director of specialty diagnostics, said in a statement.

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