A Two Arm, Multi-Site Clinical Evaluation of the ARIES HSV 1&2 Assay in Symptomatic Patients
- Conditions
- Herpes
- Registration Number
- NCT02092233
- Lead Sponsor
- Luminex Corporation
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1963
The specimen is from one of the following lesion sources: male internal and external anogenital, female internal anogenital, female external anogenital, oral or skin The specimen is collected and maintained in unexpired Copan universal transport medium
The specimen was not properly collected, transported or stored according to instructions provided by Sponsor
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement). Within the first year of sample collection
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Tricore
🇺🇸Albuquerque, New Mexico, United States
Labcorp
🇺🇸Burlington, North Carolina, United States