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NCT02270099 · ClinicalTrials.gov registry record
Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic Subjects
A clinical trial, sponsored by Hologic.
- Completed
- Registry status
- 839
- Enrollment target
NCT02270099: Completed study, sponsored by Hologic.
NCT02270099 is a clinical trial that has completed, run by Hologic. The registered enrollment target is 839 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02270099 has completed, sponsored by Hologic.
- COMPLETED
- Registry status
- 839 participants
- Enrollment target
Study 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.
Primary Outcome
Sensitivity and specificity of the Aptima HSV 1 \& 2 assay will be determined by comparing assay results to results from a reference method representing the true infected status of the subjects. Sensitivity will be reported as the percentage of subjects with an HSV infection who test positive by the Aptima HSV 1 \& 2 assay. Specificity will be reported as the percentage of subjects without an HSV infection who test negative by the Aptima HSV 1 \& 2 assay.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 839 participants |
| Start Date | 2014-12 |
| Est. Completion | 2017-06 |
What the finished NCT02270099 record still lists
NCT02270099 is an observational study that tracks outcomes without assigning an intervention. The registered 839 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02270099 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02270099 about?
NCT02270099 is a clinical study titled "Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic Subjects". 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 u...
What is the current status of trial NCT02270099?
This trial is currently completed. The enrollment target is 839 participants. The study started on 2014-12. Estimated completion is 2017-06.
Who is sponsoring clinical trial NCT02270099?
This trial is sponsored by Hologic, which has 21 total clinical trials registered on ClinicalTrials.gov.
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