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CompletedNCT02270099Updated Aug 14, 2017

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

An observational study in Herpes Simplex Infections, sponsored by Hologic, Inc.. Completed at 22 sites in United States. Per ClinicalTrials.gov, last updated 2017-08-14.

Sponsored by Hologic, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
839
Sex
All
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Study 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.

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Conditions studied

  • Herpes Simplex Infections

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In context

Herpes Simplex

305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.

This study's enrollment of 839 is above the median of 180 across 55 observational studies indexed under Herpes Simplex.

Browse Herpes Simplex studies →

Lead sponsor

Hologic, Inc. is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
839 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Subjects with suspected HSV Lesions
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What researchers measure

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.

    Time frame: 1 day

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Study locations

22 sites
  • 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
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02270099
Lead sponsor
Hologic, Inc.
Responsible party
Sponsor
First posted
Oct 21, 2014
Start date
Dec 2014
Primary completion
Aug 2016
Completion
Jun 2017
Last update
Aug 14, 2017

Study contacts

Rainer Ziermann
study director · Hologic, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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