Chinese approval for Diagnostic Hybrids' D3 Ultra respiratory virus test
This article was originally published in Clinica
Executive Summary
The Chinese state FDA (SFDA) has approved Diagnostic Hybrids' D3 Ultra DFA (direct fluorescence assay) respiratory virus screening and ID kit. The test can identify influenza A and B, parainfluenza 1, 2 and 3, respiratory syncytial virus and adenovirus. It can test patient specimens directly, providing results in 15 minutes, or cell culture, in combination with the firm's R-Mix and R-Mix Too Mixed FreshCells cell culture systems, giving results in 24-48 hours. Diagnostic Hybrids (Athens, Ohio), which became a subsidiary of Quidel after its acquisition in February, claims that the product is a market leader in the US clinical virology testing market. It was first cleared by the FDA in January 2006.