The test was previously approved to detect and differentiate carbapenemase genes from bacterial isolates, and now has an expanded claim for testing directly from rectal swabs.
The multiplex qPCR test can detect and discriminate herpes simplex virus 1 and 2 as well as varicella zoster virus, which can be mistaken for HSV in a proportion of cases.
The study involved 11 sites and 1,560 prospectively collected patient samples and demonstrated high overall positive and negative percent agreement with comparator assays.