Multicenter Performance Study of QuadQuik Invitro Diagnostic Device
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Standard performance criteria
研究概览
简要总结
To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device
详细描述
Measurement Methodology Whole blood samples are collected by fingerstick. Samples tested immediately.
Using the supplied sample dropper, transfer specimen blood drop into the two sample wells. Wait 20-30 seconds. Add two drops of the supplied assay buffer (~90µL) to the same sample wells Read result in 20 mins.
Primary end points will determine how accurate these tests are (p<=0.02) by analyzing for:
Diagnostic Sensitivity; TP / (TP + FN) The ability of the test to correctly identify those patients with the disease Diagnostic Specificity; TN / (TN + FP) The ability of the test to correctly identify those patients who are truly free of the specific disease Positive Predictive Value: TP / (TP+ FP) The probability that subjects with a positive test truly have the disease. Negative Predictive Value: TN / (FN + TN) The probability that subjects with a negative test truly don't have the disease.
An estimated 200 patients are to be enrolled as follows:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a documented medical history of HIV, HBV, HCV or syphilis. A combination of 2 or 3 conditions is acceptable.
- •HbsAg patients need to have a HbsAg on file < 2 years. HIV and HCV patients only need one antibody test in their medical chart. no documented medical history of HIV, HBV, HCV or syphilis and are considered normal.
- •Male or female subjects, ages ≥18 years. Signed informed consent provided by an authorized subject representative (based on local Institutional Review Board (IRB)/ethics panel requirements).-
排除标准
- •Any other condition or prior therapy, which, in the opinion of the investigator, would make the subject unsuitable for this study.
- •Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days before randomization.-
结局指标
主要结局
Standard performance criteria
时间窗: <1 day
Diagnostic Sensitivity, Diagnostic Specificity, Positive Predictive Value, Negative Predictive Value
次要结局
未报告次要终点