中文摘要：

目的建立一种简便、灵敏和准确的多通道电化学传感器分析方法（ECISA）,用于人血清总前列腺特异性抗原（tPSA）的检测,并进行性能评价。方法基于抗体真空组装技术,将抗PSA抗体在16通道碳印刷电极阵列表面进行自组装,结合双抗体夹心免疫分析原理和多通道电化学传感技术对185份人血清中的tPSA进行检测,并将结果与电化学发光免疫分析法（ECLIA）进行相关性分析。结果多通道电化学传感技术检测tPSA标准曲线的线性范围为0.05-50 ng/mL;tPSA的最低检测限为10 pg/mL;定量限为61 pg/mL;检测tPSA批内变异系数（CV）为8.00%-8.50%;与ECLIA定量结果相关性良好（r2=0.941,P〈0.01）。结论 ECISA技术检测tPSA的灵敏度和特异性均较高,且与ECLIA结果有较好的相关性,能满足临床对tPSA检测的要求,具有潜在的临床推广应用价值,并具备用于其他肿瘤标志物检测的前景。

英文摘要：

Objective To establish a simple, sensitive and specific method to detect human serum total prostate-specific antigen （tPSA） based on multichannel electrochemical immunosensor arrays （ECISA） and evaluate its performance. Methods Anti-PSA an tibody was immobilized on a disposable 16-channel screen-printed carbon electrode array by an antibody vacuum assembly strategy. Then, the established muhiehannel ECISA combined with sandwich immununoassay, was used to detect the levels of tPSA in 185 human serum samples and the obtained results were compared with those detected by electrochemil immunoassay （ECLIA） Results When the established muhichannel ECISA was used to detect serum tPSA level, its linear range was 0.05-50 ng/mL for the tPSA standard curve, the limit of detection was 10 pg/mL, the limit of quantification was 61 pg/mL, and the intra-assay coefficient of variation （CV） was 8.00%-8.50%. Therewas good correlation between the results of ECISA and those of ECLIA （r2 =0. 941, P 〈 0.01 ）. Conclusion The established multichannel ECISA has high sensitivity and specificity, and good correlation with ECLIA for the detection of serum tPSA, which may be a potential tool for the detection of tPSA and other tumor markers.