NEW YORK – DiaCarta said on Wednesday that it has received the CE-IVD mark for an assay to detect and distinguish SARS-CoV-2, influenza A, and influenza B.
The company will commercialize the test in countries accepting the CE mark and is preparing to submit it to the US Food and Drug Administration for Emergency Use Authorization and 510(k) clearance.
The assay, called the QuantiVirus SARS-CoV-2 & Flu A/B Detection Test, uses real-time PCR to qualitatively detect the three viruses in a single reaction tube using nasopharyngeal swab or saliva samples.
The assay has positive predictive agreement of 99.7 percent and negative predictive agreement of 99.9 percent for SARS-CoV-2, and 100 percent, respectively, for both flu A and flu B targets, the Pleasanton, California-based firm said in a statement.
Aiguo Zhang, CEO and president of DiaCarta, said that the test complements the firm's RT-PCR tests that have EUA, adding that the firm’s test design continues to identify all new emerging SARS-CoV-2 variants, including BA 5.