Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic Subjects

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial 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.

See also
Status	Clinical Trial	Phase
Completed	`NCT02579083` - Safety Study of Monoclonal Antibodies to Reduce the Vaginal Transmission of HSV and HIV	Phase 1
Completed	`NCT02715752` - A Retrospective Chart Review Study of Gene-Eden-VIR/Novirin	N/A
Completed	`NCT01429311` - Interferon Responses in Eczema Herpeticum	N/A

NCT number	NCT02270099
Study type	Observational
Source	Hologic, Inc.
Contact
Status	Completed
Phase	N/A
Start date	December 2014
Completion date	June 2017

Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic Subjects

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms