Overview

This trial is active, not recruiting.

Condition herpes simplex infections
Sponsor Hologic, Inc.
Start date December 2014
End date August 2016
Trial size 839 participants
Trial identifier NCT02270099, A10921-HSVPS-CSP-01

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 in the male anogenital region, the female anogenital region, the oral cavity and other mucomembranous or mucocutaneous areas of the face (oral/facial), and the skin. Specimens collected using swabs from viral transport medium (VTM)collection kits and Aptima swab collection kits will be evaluated.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Evaluation of sensitivity and specificity of the Aptima HSV 1 & 2 Assay on Panther
time frame: 1 day

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - The subject has at least 1 active lesion (lesion with exudates and cellular material; eg, vesicle, ulcer) that is suspected to be caused by HSV (as determined by the clinician) - The subject and/or legally authorized representative is willing and able to provide consent prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board-approved waiver for parental consent for minors) Exclusion Criteria: - The subject has only HSV lesions without exudates and cellular material - The subject used a topical or oral antiviral medication used to treat HSV within 21 days of enrollment - Subject already participated in this study - Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the study - Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled in the study

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hologic, Inc..