Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2,296
- 试验地点
- 7
- 主要终点
- Prevalence of CT and/or GC disease by clinical site
研究概览
简要总结
Multicenter clinical study to test a new qualitative in vitro nucleic acid amplification assay based on kPCR technology. The assay is intended for the diagnosis of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC).
详细描述
The study was terminated
This clinical trial protocol outlines the analytical and clinical performance characteristics that will be evaluated to demonstrate equivalency of the VERSANT CT/GC DNA 1.0 (kPCR) Assay for product registration. The Gen-Probe APTIMA Combo 2 Assay will be used as the CE-marked comparative method. The studies conducted during the clinical trial are intended to provide data to support the safety and effectiveness, as well as the labeling claims for the VERSANT CT/GC Assay. The study objectives are as follows:
- To demonstrate concordance with the Gen-Probe APTIMA Combo 2 Assay;
- To estimate the positive and negative predictive values for each specimen type included in the study;
- To estimate the indeterminate rate for each specimen type included in the study;
- To estimate the equivocal rate for each specimen type; and
- To assess reproducibility of the VERSANT CT/CG DNA 1.0 Assay (kPCR) using the VERSANT kPCR Molecular System.
Two (2) studies will be conducted to validate the analytical and clinical performance characteristics of the CT/GC DNA 1.0 (kPCR) Assay. Table 1 provides an overview of these studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 years of age or older.
- •Subject signed an IRB approved informed consent form.
- •Subject is able to follow verbal and written instructions.
排除标准
- •Subject has been on antibiotic therapy within 21 days prior to study enrollment.
- •Subject urinated within one hour prior to sample collection.
结局指标
主要结局
Prevalence of CT and/or GC disease by clinical site
时间窗: Study terminated
次要结局
未报告次要终点