Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic Subjects
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)
1 other identifier
observational
839
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2014
Typical duration for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2014
CompletedFirst Posted
Study publicly available on registry
October 21, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedAugust 14, 2017
August 1, 2017
1.7 years
October 16, 2014
August 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of sensitivity and specificity of the Aptima HSV 1 & 2 Assay on Panther
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.
1 day
Study Arms (1)
Subjects with suspected HSV Lesions
Eligibility Criteria
Male and female subjects attending participating US collection sites and presenting with suspected HSV lesion(s) will be eligible for the study. Sites may include family planning, general practice, dermatology, research, sexually transmitted infection, adolescent, and public health clinics. There are no age restrictions for this study.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hologic, Inc.lead
Study Sites (22)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, 85018, United States
Sherif Khamis MD, Inc
Canoga Park, California, 91303, United States
Mills Clinical Research
Los Angeles, California, 90069, United States
Planned Parenthood of the Rocky Mountains
Denver, Colorado, 80206, United States
Yale School of Medicine
New Haven, Connecticut, 06510, United States
Perimeter Institute for Clinical Research, Inc. (PICR Clinic)
Atlanta, Georgia, 30338, United States
Advanced Clinical Research
Boise, Idaho, 83642, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
LSU Health Science Center
New Orleans, Louisiana, 70112, United States
LSU Health Science Center - Shreveport
Shreveport, Louisiana, 71103, United States
IRC Clinics
Towson, Maryland, 21204, United States
University of Mississippi Medical Center/Crossroads Clinic (MSDH)
Jackson, Mississippi, 39216, United States
Quality Clinical Research Inc.
Omaha, Nebraska, 68114, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Laboratory Corporation of America
Burlington, North Carolina, 27215, United States
Westover Heights Clinic
Portland, Oregon, 97210, United States
Planned Parenthood of Southeastern Pennsylvania
Philadelphia, Pennsylvania, 19107, United States
Geneuity Clinical Research Services
Maryville, Tennessee, 37804, United States
Planned Parenthood Gulf Coast, Inc.
Houston, Texas, 77023, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
American Regional University Pathologists
Salt Lake City, Utah, 84108, United States
Biospecimen
lesion swab
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rainer Ziermann
Hologic, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2014
First Posted
October 21, 2014
Study Start
December 1, 2014
Primary Completion
August 1, 2016
Study Completion
June 1, 2017
Last Updated
August 14, 2017
Record last verified: 2017-08