Comparative evaluation of Savanna HSV 1+2/VZV multiplex assay and Simplexa HSV 1&2 and VZV direct kits for rapid molecular detection of HSV-1, HSV-2, and VZV.

Herpes simplex virus (HSV-1 and HSV-2) and varicella-zoster virus (VZV) cause cutaneous and mucocutaneous lesions. Primary infection and secondary reactivations affect the mouth, genitalia, and dermis at other bodily regions. Accurate clinical diagnosis without laboratory confirmation can be difficult since lesions caused by these viruses are nondescript, and areas of bodily infection can overlap. Rapid molecular test results have been shown to reduce the time to definitive diagnosis, providing additional opportunities for patient counseling, antiviral therapy, and appropriate infection prevention measures. A molecular, multiplexed HSV + VZV assay allows both viruses to be tested simultaneously from a single lesion swab. This could potentially enhance diagnostic accuracy through laboratory confirmation, thus minimizing dependence on clinical judgment alone. The recently Food and Drug Administration (FDA)-approved Savanna HSV 1+2/VZV multiplex assay has not been widely evaluated against other FDA-approved assays. This is the first report evaluating the clinical performance of the Savanna HSV 1+2/VZV assay compared to independent assays for HSV and VZV. Results indicated that the Savanna HSV 1+2/VZV assay was comparable to the Diasorin Simplexa HSV 1&2 Direct and VZV Direct assays.IMPORTANCELesion-causing viruses, herpes simplex (HSV-1 and HSV-2) and varicella-zoster virus (VZV), are common and difficult to distinguish clinically. Each can be found over any area of the body but have different treatment regimens and considerations for infectivity and future outbreak management. Laboratory analysis by molecular assay is the gold standard for these viruses, but it can take hours to days and is reliant on the clinician choosing the correct virus to test the first time, or risk being outside the treatment window. A rapid molecular assay that detects all three viruses simultaneously was developed and recently approved by the Food and Drug Administration (FDA). Here, we provide data highlighting the clinical performance of the Savanna HSV 1+2/VZV assay and its ability to detect across anatomical locations and ages. These data indicate that the Savanna assay is comparable to individual assays for each viral target, providing the opportunity for enhanced diagnostic accuracy of lesions.