【摘要】 目的 评价ELISA方法对无偿献血者梅毒抗体的筛检价值。方法 以卫生部临床检验中心梅毒抗体临床科研血清盘血清40份及随机抽取100份西安市无偿献血者阴性血清为评价标本，采用厦门英科新创梅毒抗体ELISA诊断试剂盒(ELISA1)和北京金豪梅毒抗体ELISA诊断试剂盒(ELISA2)对评价标本作盲法筛检，以卫生部临床检验中心血清盘作为金标准，用四格表法计算评价真实性与可靠性指标，并对Cut-off值的合理性进行评价。结果 ELISA1及ELISA2的灵敏度分别为95.5%，100.0%，特异度分别为94.4%，94.4%，约登指数分别为0.90，0.94，两种试剂的重复符合率均为100.0%，两种试剂的Cut-off值是合理的。结论 两种试剂联合筛检可保证输血的安全性，如果能进一步提高试剂的灵敏度与特异度，将会具有更大的临床应用价值。

    关键词 梅毒抗体 ELISA 献血者

    Evaluation of ELISA method on screening blood donors treponema pallidum antibody

    Zhang Xianqing，Sun Wenli，Mu Shijie，et al.

    Department of Blood Transfusion，Xijing Hospital，the Fourth Military Medical University，Xi′an710032.

    【Abstract】 Objective To evaluate ELISA method on screening blood donors′treponema pallidum(TP)antiˉbody.Methods Samples for evaluation included40TP serum plates for clinical scientific reseach from clinical testing center of the Ministry of Health and100sets of TP antibody negative serum from blood donors in Xi′an city.The samˉples underwent blind screeing with TP antibody ELISA diagnostic kits of Xiamen Intec(ELISA1)and TP antibody ELISA diagnostic kit of Beijing Kinghawk(ELISA2).With the serum plates from clinical testing center of the Ministry of Health as the golden criteria ......