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NEW YORK – DiaCarta said on Thursday that it has obtained Emergency Use Authorization from the US Food and Drug Administration for its QuantiVirus PCR diagnostic (Dx) test for the novel coronavirus.

The test detects the N, Orf1ab, and E genes of the SARS-CoV-2 virus in nasopharyngeal swabs, oropharyngeal swabs, and sputum samples from individuals suspected by their healthcare providers of having COVID-19. It uses real-time quantitative reverse transcriptase PCR and has a limit of detection of 100 copies/mL without detectable cross-reactivity to other human respiratory pathogens.

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