DiaCarta Earns CE Mark for Coronavirus Test

DiaCarta has received CE Mark certification for its QuantiVirus SARS-CoV-2 diagnostic test validated at its Richmond, California lab.

The in-vitro diagnostic uses real-time PCR technology to detect the virus in respiratory swabs. Clinical validation showed it has a 96.7 percent sensitivity and no cross-reaction to other non-SARS-CoV-2 species.

The real-time PCR assay targets three genes of SARS-CoV-2 to ensure a high degree of sensitivity and accuracy, the company said.