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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT02092233
Study type Observational
Source Luminex Molecular Diagnostics
Contact
Status Completed
Phase N/A
Start date January 2014

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