Oberpenning Frank, Hetzel Stefan, Weining Christoph, Brandt Burkhard, De Angelis Gabriela, Heinecke Achim, Lein Michael, Fornara Paolo, Schmid Hans-Peter, Hertle Lothar, Semjonow Axel
Department of Urology, University of Münster, Albert-Schweitzer Str. 33, D-48129, Münster, Germany.
Eur Urol. 2003 May;43(5):478-84. doi: 10.1016/s0302-2838(03)00095-2.
A strip test for the semi-quantitative determination of prostate specific antigen (PSA) based on whole blood was evaluated by the Working Group on Laboratory Diagnostics of the German Urological Association.
In 301 men (156 volunteers and 145 referred patients, mean ages 57 years and 64 years) handling and capability of the strip test to predict PSA serum concentrations (Access Hybritech, Beckman Coulter, Inc., Fullerton, CA, USA) relative to a cutoff of 4 micro g/l were investigated. For patients, the strip test was performed by investigators, volunteers accomplished it according to leaflet instructions. Each test result was interpreted by both, the patient/volunteer and an investigator.
24% of the volunteers required assistance with test performance. The overall agreement between Access PSA (range 0.1-29.7) and strip test was 76% (read by participants) and 79% (read by investigators). Within the PSA ranges 0.1-3, 3.1-5 and 5.1-10, participants yielded agreement rates of 89%, 40% and 56%, respectively. Studying the 2.1-10 PSA range most relevant for prostate cancer screening, agreement rate (53%), sensitivity (50%) and specificity (67%) were barely superior to random chance. Volunteers alone (PSA range 0.1-11.3 micro g/l) yielded a specificity of 92%, however, all PSA values above the cutoff (n=8) went unrecognized and all positive strip tests (n=12) were incorrect (sensitivity 0%, positive predictive value 0%).
Test handling and interpretation was difficult. The rate of false strip test results is disappointing even for PSA ranges remote from the cutoff. In its present form the strip test fails to meet the clinical requirements and its launch to the market was therefore discontinued.
德国泌尿外科学会实验室诊断工作组对一种基于全血的前列腺特异性抗原（PSA）半定量快速检测试纸进行了评估。
对301名男性（156名志愿者和145名转诊患者，平均年龄分别为57岁和64岁）进行研究，考察该快速检测试纸相对于4μg/l临界值预测PSA血清浓度（美国加利福尼亚州富勒顿市贝克曼库尔特公司的Access Hybritech检测法）的操作情况及能力。对于患者，由研究人员进行快速检测试纸检测，志愿者则按照说明书进行操作。每个检测结果由患者/志愿者和研究人员分别解读。
24%的志愿者在检测操作上需要帮助。Access PSA检测结果（范围为0.1 - 29.7）与快速检测试纸之间的总体一致性，由参与者解读时为76%，由研究人员解读时为79%。在PSA范围0.1 - 3、3.1 - 5和5.1 - 10内，参与者的一致性率分别为89%、40%和56%。研究对前列腺癌筛查最相关的2.1 - 10 PSA范围时，一致性率（53%）、灵敏度（50%）和特异性（67%）仅略优于随机概率。仅志愿者（PSA范围0.1 - 11.3μg/l）的特异性为92%，然而，所有高于临界值的PSA值（n = 8）均未被识别，所有快速检测试纸阳性结果（n = 12）均不正确（灵敏度0%，阳性预测值0%）。
检测操作和解读都很困难。即使对于远离临界值的PSA范围，快速检测试纸的错误结果率也令人失望。以其目前的形式，该快速检测试纸无法满足临床需求，因此停止了推向市场的计划。
