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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02270099

Enrollment

839

Registered

2014-10-21

Start date

2014-12-31

Completion date

2017-06-30

Last updated

2017-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Simplex Infections

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results