A Two Arm, Multi-Site Clinical Evaluation of the ARIES HSV 1&2 Assay in Symptomatic Patients

The ARIES HSV 1\&2 Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and typing of herpes simplex virus (HSV 1 \& 2) DNA in male external and internal anogenital, female external and internal anogenital (vaginal), oral and skin lesion specimens. The objective is to establish the diagnostic accuracy of ARIES HSV-1\&2 Assay through a multi-site, method comparison on prospectively collected, left-over de-identified, clinical specimens (i.e. all-comers accrued at enrolled clinical sites between pre-determined dates) as an aid in the diagnosis of herpes infection.