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

Hologic

Status: Completed

Conditions: Herpes Simplex Infections

Study type: Observational

Funder types: Industry

Identifiers

NCT02270099

A10921-HSVPS-CSP-01

Details and patient eligibility

About

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.

Enrollment: 839 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

839 participants in 1 patient group

Subjects with suspected HSV Lesions