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Quidel gets EUA for QuickVue SARS rapid antigen test

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Dec. 22, 2020 —Quidel announced it received emergency use authorization from the FDA to market its QuickVue SARS Antigen test, a point-of-care assay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nares swab specimens from people who are suspected of having COVID-19 by their health care provider within the first five days of symptom onset.

The test offers excellent performance for the detection of SARS-CoV-2—96.6 percent positive percent agreement and 99.3 percent negative percent agreement versus PCR—with test results available in 10 minutes.

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