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DiaCarta SARS-CoV-2 Test Kit Receives CE Mark

NEW YORK – Molecular diagnostic firm DiaCarta said on Monday that its QuantiVirus SARS-CoV-2 test recently received the CE mark. The firm has also filed for Emergency Use Authorization of the test with the US Food and Drug Administration.

The company's qRT-PCR test detects viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs, and sputum. it targets three genes of SARS-CoV-2: the N, Orf1ab, and E genes.

The test, which was clinically validated in the company's CLIA-certified lab in Richmond, California, has 96 percent sensitivity and 100 percent specificity, according to DiaCarta, and doesn't cross-react with other types of coronaviruses.