NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Compare NOWDx HSV-2 Test result to comparator method lab result to assess sensitivity and specificity of investigational device.
研究概览
简要总结
This study is designed to compare the performance of the NOWDx HSV-2 Test to a currently marketed device. The intent is to show the rapid test device is comparable to the currently marketed device. The NOWDx HSV-2 Test is intended for qualitatively detecting the presence or absence of human Immunoglobulin G (IgG) class antibodies to HSV-2 in human whole blood to aid in the diagnosis of infection caused by herpes simplex virus type 2 (HSV-2).
详细描述
The objective of this study is to establish the performance characteristics of the NOWDx HSV-2 Test based on comparison to the HerpeSelect 1 and 2 Immunoblot IgG and HerpeSelect 2 ELISA IgG assays.
The external clinical study along with in-house analytical studies will demonstrate the efficacy of the NOWDx HSV-2 Test as an aid in the diagnosis of HSV-2 infection for at home testing and point of care testing sites. Participants will self test and be tested by Clinical Laboratory Improvement Amendments (CLIA) Waived operators with the NOWDx HSV-2 Test at independent sites in Florida, Kentucky, and Arizona.
Two sample types will be tested with the NOWDx HSV-2 Test for each participant: capillary whole blood and venous whole blood. Sera from each participant will be tested at an independent reference laboratory.
The NOWDx HSV-2 Test will be evaluated in diverse populations of sexually active persons who self-select for genital herpes testing, expectant mothers, and persons claiming to lack sexual experience.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Compare NOWDx HSV-2 Test result to comparator method lab result to assess sensitivity and specificity of investigational device.
时间窗: through study completion, an average of 6 months
The results should be presented as sensitivity and specificity as compared to the comparator method and should have a point estimate of 95% with a lower bound of the two-sided 95% confidence interval of 90%.
次要结局
- Compare results of NOWDx HSV-2 Tests conducted by lay users with expected results to evaluate test reproducibility by lay users.(through study completion, an average of 6 months)