Validation of a Semiquantitative Screening Assay for PSA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Determination of the sensitivity and specificity of the rapid PSA assay by comparing the results obtained from the test strip reading by three independent blinded observers with those from standard plasma PSA assay.
研究概览
简要总结
The aim of the study is to compare the diagnostic performances of a simple and rapid PSA assay on whole blood to the standard plasma PSA assay.
详细描述
Screening and surveillance of prostate cancer typically involves sensitive laboratory techniques for the quantification of plasma prostate specific antigen (PSA). In this study, we determine the sensitivity and specificity of a simple test strip based PSA assay using only a few drops of whole blood as compared to a standard plasma PSA assay. Blood samples will be taken from hundred patients who are followed for a prostatic disease needing PSA surveillance. Before decantation of the samples, a few drops of blood will serve for the rapid test on strips. Plasma PSA levels will be determined with the TRACE ("Time Resolved Amplified Cryptate Emission") technology in homogeneous liquid phase. The results from the rapid test can then be compared to the plasma levels obtained by TRACE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients followed for prostate cancer or symptomatic benign prostatic disease, and for who a PSA assay is indicated.
- •Patients must have given informed consent.
排除标准
- •Patients followed for a disease other than prostatic.
结局指标
主要结局
Determination of the sensitivity and specificity of the rapid PSA assay by comparing the results obtained from the test strip reading by three independent blinded observers with those from standard plasma PSA assay.
时间窗: day of test
次要结局
- Determination of the threshold which maximizes the performance of the semiquantitative test. Determination of interobserver agreement.(at the last inclusion)