日本血吸虫抗体检测试剂盒(IHA法)的研制与应用

Development and assessment of Schistosoma japonicum antibody test kit(IHA)

目的研制日本血吸虫抗体检测试剂盒(IHA法)。方法按《药品生产质量管理规范》要求,研究日本血吸虫抗体检测试剂盒(IHA法)组成成份、制备方法及程序,并对研制的试剂盒进行诊断效果评价。结果研制的日本血吸虫抗体检测试剂盒(IHA法)检测慢性血吸虫病患者敏感性为94.49%,检测健康人群特异性为97.14%,Youden指数为0.92;与并殖吸虫和旋毛虫病患者血清交叉反应率分别为15.00%和10.00%。与市售日本裂体吸虫抗体检测试剂盒(ELISA法)和日本血吸虫抗体检测试剂盒(IHA法)平行检测流行区居民血吸虫抗体的总体符合率分别为93.06%和92.25%。结论日本血吸虫抗体检测试剂盒(IHA法)敏感性高、特异性强,适合疫区现场血吸虫病筛查,具有推广应用价值。

Objective To develop a Schistosoma japonicum antibody test kit（IHA）. Methods According to the requirement of Good Manufacturing Practice（GMP）and Quality Control（QC）of drugs,the components of kit as well as its preparation method and procedure were studied,and the test kit was assembled and its diagnostic effect was assessed. Results The sensitivity and specificity were up to 94.49% and 97.14% when testing the serum samples of chronic schistosomiasis patients and normal serum samples by the kit,respectively. The Youden Index of the Kit was 0.92. The cross reaction rates with paragonimus and trichina were 15.00% and 10.00%,respectively. Compared with ELISA and another IHA kit produced by An＇Ji company which were used to test schistosome antibody in residents of endemic areas at the same time,the coincident rates of the developed kit were 93.06% and 92.25%,respectively. Conclusion The IHA kit for Schistosoma japonicum antibody has a high sensitivity and specificity,and has the value of application and popularization in the field.