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.
Study Type
OBSERVATIONAL
Enrollment
1,963
Baystate Medical Center
Springfield, Massachusetts, United States
Tricore
Albuquerque, New Mexico, United States
Labcorp
Burlington, North Carolina, United States
Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
Time frame: Within the first year of sample collection
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