Herpes Clinical Trial
Official title:
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 PCR based test for the direct detection and typing of herpes
simplex virus (HSV 1 & 2) DNA.
The objective is to establish the diagnostic accuracy of ARIES HSV-1&2 Assay.
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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