Trials / Completed
CompletedNCT02092233
A Two Arm, Multi-Site Clinical Evaluation of the ARIES HSV 1&2 Assay in Symptomatic Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,963 (actual)
- Sponsor
- Luminex Corporation · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2015-03-01
- First posted
- 2014-03-20
- Last updated
- 2015-07-10
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02092233. Inclusion in this directory is not an endorsement.