September 3, 2015
Quest Diagnostics announced today that the FDA has given the company clearance to add a genital swab claim to its molecular test for herpes simplex virus types 1 and 2, according to a press release.
The Simplexa HSV 1 & 2 Direct molecular test is the first FDA-approved assay to use cerebrospinal fluid from patients suspected of herpes simplex virus (HSV) central nervous system infection, including encephalitis, according to the release. The test is designed to be used on the 3M Integrated Cycler and uses real-time PCR technology to detect DNA or RNA of viruses, bacteria and other substances. It uses a proprietary process that eliminates nucleic acid extraction, and results are delivered in approximately 1 hour.