Evaluation of a rapid quantitative determination method of PSA concentration with gold immunochromatographic strips.
Evaluation of a rapid quantitative determination method of PSA concentration with gold immunochromatographic strips.
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DOI：
10.1186/s12894-015-0105-7
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发表时间：
2015-11-03
期刊：
影响因子：
2
通讯作者：
Hu JJ
中科院分区：
文献类型：
--
作者：
Wu CC;Lin HY;Wang CP;Lu LF;Yu TH;Hung WC;Houng JY;Chung FM;Lee YJ;Hu JJ
前列腺癌仍然是男性最常见的癌症。前列腺特异性抗原（PSA）的定性或半定量免疫层析测量已被证明是简单，无创和可行的。本研究的目的是评价一种用于检测PSA的优化的金免疫层析试纸条装置，其中可以使用显色快速检测读数器对结果进行分析，以定量评估检测结果。该读取器通过电荷耦合器件相机测量信号线的反射率。对于定量分析，通过校准方程计算PSA浓度。对305名男性的毛细血管血液样本进行了评估，12分钟后由两名独立的观察员解释测试结果。还收集了血液样品，并用常规定量测定法进行了检测。PSA快速定量检测系统的敏感性、特异性、阳性和阴性预测值以及准确性分别为100%、96.6%、89.5%、100%和97.4%。该试验的重现性为99.2，观察者间变异为8%，假阳性率为3.4%.普通定量法与快速定量法的相关系数为0.960。PSA快速定量测试系统提供快速结果并且易于使用，因此使用该系统的测试可以在门诊诊所或其他地方容易地进行。该系统也可用于初始癌症筛查和即时检测，因为可以在12分钟内获得结果，并且成本低于常规定量测定。
Prostate cancer remains the most common cancer in men. Qualitative or semi-quantitative immunochromatographic measurements of prostate specific antigen (PSA) have been shown to be simple, noninvasive and feasible. The aim of this study was to evaluate an optimized gold immunochromatographic strip device for the detection of PSA, in which the results can be analysed using a Chromogenic Rapid Test Reader to quantitatively assess the test results. This reader measures the reflectance of the signal line via a charge-coupled device camera. For quantitative analysis, PSA concentration was computed via a calibration equation. Capillary blood samples from 305 men were evaluated, and two independent observers interpreted the test results after 12 min. Blood samples were also collected and tested with a conventional quantitative assay. Sensitivity, specificity, positive and negative predictive values, and accuracy of the PSA rapid quantitative test system were 100, 96.6, 89.5, 100, and 97.4 %, respectively. Reproducibility of the test was 99.2, and interobserver variation was 8 % with a false positive rate of 3.4 %. The correlation coefficient between the ordinary quantitative assay and the rapid quantitative test was 0.960. The PSA rapid quantitative test system provided results quickly and was easy to use, so that tests using this system can be easily performed at outpatient clinics or elsewhere. This system may also be useful for initial cancer screening and for point-of-care testing, because results can be obtained within 12 min and at a cost lower than that of conventional quantitative assays.