Trials / Completed
CompletedNCT02270099
Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic Subjects
Clinical Evaluation of the Aptima® Herpes Simplex Viruses 1 & 2 Assay on the Panther® System in Swab Specimens From Symptomatic Subjects Presenting With a Suspected Herpes Lesion(s)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 839 (actual)
- Sponsor
- Hologic, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This clinical performance study is being conducted to evaluate the performance of the Aptima Herpes Simplex Viruses 1 \& 2 assay for detection of herpes simplex virus (HSV) type 1 (HSV-1) and HSV type 2 (HSV-2) in swab samples prospectively collected from suspected HSV lesions. Specimens collected using swabs from viral transport medium (VTM)collection kits and Aptima swab collection kits will be evaluated.
Conditions
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2016-08-01
- Completion
- 2017-06-01
- First posted
- 2014-10-21
- Last updated
- 2017-08-14
Locations
22 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02270099. Inclusion in this directory is not an endorsement.