A Two Arm, Multi-Site Clinical Evaluation of the ARIES HSV 1&2 Assay in Symptomatic Patients
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 1500
Summary
- Conditions
- Herpes
- Type
- Observational
- Design
- Observational Model: Case-Only
- Time Perspective: Prospective
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
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 specim...
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.
Tracking Information
- NCT #
- NCT02092233
- Collaborators
- Not Provided
- Investigators
- Study Director: David Himsworth Luminex Corporation
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