Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic Subjects
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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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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