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Trial record 76 of 126 for:    HSV-2

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

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ClinicalTrials.gov Identifier: NCT02270099
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Herpes Simplex Infections

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Study Type : Observational
Actual Enrollment : 839 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Study Start Date : December 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herpes Simplex

Group/Cohort
Subjects with suspected HSV Lesions



Primary Outcome Measures :
  1. Evaluation of sensitivity and specificity of the Aptima HSV 1 & 2 Assay on Panther [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
lesion swab


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270099


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Sponsors and Collaborators
Hologic, Inc.
Investigators
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Study Director: Rainer Ziermann Hologic, Inc.

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Responsible Party: Hologic, Inc.
ClinicalTrials.gov Identifier: NCT02270099     History of Changes
Other Study ID Numbers: A10921-HSVPS-CSP-01
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases