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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 839
- 试验地点
- 22
- 主要终点
- Evaluation of sensitivity and specificity of the Aptima HSV 1 & 2 Assay on Panther
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Evaluation of sensitivity and specificity of the Aptima HSV 1 & 2 Assay on Panther
时间窗: 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.
次要结局
未报告次要终点