华支睾吸虫半胱氨酸蛋白酶ELISA检测方法的建立及其应用效果评价

目的建立重组华支睾吸虫半胱氨酸蛋白酶ELISA检测方法，观察该方法检测华支睾吸虫病的现场应用效果。方法根据江苏省第二次重要人体寄生虫流行现状调查结果选取6个调查点，采用整群抽样的方法每个村调查不少于500人，应用重组华支睾吸虫半胱氨酸ELISA检测血清特异性抗体。采用系统抽样方法抽取的10％的阴性者和全部阳性者开展病原学检测。ELISA试验通过设立阴性血清、阳性血清和PBS对照及重复试验进行质量控制。结果ELISA检测3105人，血清特异性抗体阳性21人，阳性率为0．68％。对ELISA阳性者做病原学检查，阳性18人，一致率为99．10％。质量控制结果显示ELIsA试验，每批次阴性和阳性平行对照A。均值差异无统计学意义（P〉0．05），重复试验一致率为99．43％。结论重组华支睾吸虫半胱氨酸蛋白酶ELISA法重复性好，敏感性高，具有较高的诊断价值和广阔的应用前景。

Evaluation on effect of detecting clonorchiasis with ELISA coated by the antigen of cysteine protease

Objective To found the serodiagnosis method of ELISA coated by recombinant eysteine protease of clonorchis sinensis and evaluate the diagnostic effect for clonorchiasis. Mehtods Based on the second investigation re- sult of human key parasite epidemic status in Jiangsu province, 6 counties were chosen. And more than 500 people were detected each village with cluster sampling. All of positive respondents and 10.00% negative respondents selected by sys- tem sampling were detected again with Kato-Katz. Meanwhile, some measures were implemented, including negative ser- um control, positive serum control, blank control and repeated detection, for controling strictly the detecting quality. Results 3 105 of sera were collected from 6 investigation sites. There were only 18 positive people with Kato Katz, all of who were from positive respondents identified by serodiagnosis with recombinant cysteine protease of clonorchis sinensis. And the total concordance rate was 99.10%. There were no statistics difference in the mean values of um control and negative serum control between each batch detection （P〉0.05）. And the concordance tection was 99.43 %. Conclusion It is high diagnostic value for clonorchiasis with ELISA coated by ine protease of clonorchis sinensis in filed application. OD of positive ser rate of repeated de recombinant cyste