DiaCarta’s SARS-CoV-2 and Flu A/B Test Gets CE-IVD Mark

Pleasanton, Calif.-based DiaCarta has received a CE-IVD mark for its QuantiVirus SARS-CoV-2 & Flu A/B test.

The real-time polymerase chain reaction test can detect nucleic acid from both the SARS-CoV-2 virus and influenza viruses in nasopharyngeal swab or saliva from individuals suspected of COVID-19 or influenza.

The test has 99.7 percent accuracy for identifying positive samples and 99.9 percent accuracy for detecting negative samples, the company said.

DiaCarta said it is launching the device in countries that accept the CE-IVD mark. The company also plans on submitting the test to the FDA for Emergency Use Authorization and 510(k) clearance.