DiaCarta Gets FDA Emergency Use Authorization for Coronavirus PCR Test (Genome Web)

DiaCarta Gets FDA Emergency Use Authorization for Coronavirus PCR Test

UF Innovate | Sid Martin Biotech alum DiaCarta, a molecular diagnostic firm, has obtained the 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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