Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic Subjects
- Conditions
- Herpes Simplex Infections
- Registration Number
- NCT02270099
- Lead Sponsor
- Hologic, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 839
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of sensitivity and specificity of the Aptima HSV 1 & 2 Assay on Panther 1 day 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
Perimeter Institute for Clinical Research, Inc. (PICR Clinic)
🇺🇸Atlanta, Georgia, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Planned Parenthood Gulf Coast, Inc.
🇺🇸Houston, Texas, United States
Mills Clinical Research
🇺🇸Los Angeles, California, United States
University of Mississippi Medical Center/Crossroads Clinic (MSDH)
🇺🇸Jackson, Mississippi, United States
Sherif Khamis MD, Inc
🇺🇸Canoga Park, California, United States
LSU Health Science Center
🇺🇸New Orleans, Louisiana, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
Planned Parenthood of Southeastern Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
LSU Health Science Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Planned Parenthood of the Rocky Mountains
🇺🇸Denver, Colorado, United States
Westover Heights Clinic
🇺🇸Portland, Oregon, United States
Geneuity Clinical Research Services
🇺🇸Maryville, Tennessee, United States
Advanced Clinical Research
🇺🇸Boise, Idaho, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Quality Clinical Research Inc.
🇺🇸Omaha, Nebraska, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
IRC Clinics
🇺🇸Towson, Maryland, United States
Laboratory Corporation of America
🇺🇸Burlington, North Carolina, United States
American Regional University Pathologists
🇺🇸Salt Lake City, Utah, United States
Elite Clinical Studies, LLC
🇺🇸Phoenix, Arizona, United States