Wu Cheng-Ching, Lin Hung-Yu, Wang Chao-Ping, Lu Li-Fen, Yu Teng-Hung, Hung Wei-Chin, Houng Jer-Yiing, Chung Fu-Mei, Lee Yau-Jiunn, Hu Jin-Jia
Institute of Biomedical Engineering, National Cheng Kung University, Tainan, 70101, Taiwan.
Division of Cardiology, Department of Internal Medicine, E-Da Hospital, I-Shou University, Kaohsiung, 82445, Taiwan.
BMC Urol. 2015 Nov 3;15:109. doi: 10.1186/s12894-015-0105-7.
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.
前列腺癌仍然是男性中最常见的癌症。前列腺特异性抗原（PSA）的定性或半定量免疫层析检测已被证明是简单、无创且可行的。本研究的目的是评估一种优化的金免疫层析试纸条装置用于检测PSA，其结果可使用比色快速检测读数仪进行分析以定量评估检测结果。
该读数仪通过电荷耦合器件相机测量信号线的反射率。进行定量分析时，通过校准方程计算PSA浓度。对305名男性的毛细血管血样进行评估，两名独立观察者在12分钟后解读检测结果。同时采集血样并用传统定量检测方法进行检测。
PSA快速定量检测系统的灵敏度、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%。检测的可重复性为99.2%，观察者间差异为8%，假阳性率为3.4%。常规定量检测与快速定量检测之间的相关系数为0.960。
PSA快速定量检测系统出结果快且易于使用，因此使用该系统的检测可在门诊或其他地方轻松进行。该系统对于初始癌症筛查和即时检测也可能有用，因为可在12分钟内获得结果，且成本低于传统定量检测。
