A Two Arm, Multi-Site Clinical Evaluation of the ARIES HSV 1&2 Assay in Symptomatic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,963
- 试验地点
- 3
- 主要终点
- Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
研究概览
简要总结
The ARIES HSV 1&2 Assay is a PCR based test for the direct detection and typing of herpes simplex virus (HSV 1 & 2) DNA.
The objective is to establish the diagnostic accuracy of ARIES HSV-1&2 Assay.
详细描述
The ARIES HSV 1&2 Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and typing of herpes simplex virus (HSV 1 & 2) DNA in male external and internal anogenital, female external and internal anogenital (vaginal), oral and skin lesion specimens.
The objective is to establish the diagnostic accuracy of ARIES HSV-1&2 Assay through a multi-site, method comparison on prospectively collected, left-over de-identified, clinical specimens (i.e. all-comers accrued at enrolled clinical sites between pre-determined dates) as an aid in the diagnosis of herpes infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 specimen is from one of the following lesion sources: male internal and external anogenital, female internal anogenital, female external anogenital, oral or skin The specimen is collected and maintained in unexpired Copan universal transport medium
排除标准
- •The specimen was not properly collected, transported or stored according to instructions provided by Sponsor
结局指标
主要结局
Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
时间窗: Within the first year of sample collection
次要结局
未报告次要终点