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目的对湖北省研制的日本血吸虫病间接血凝试验(IHA)试剂盒的敏感性、特异性、稳定性等指标进行综合评价。方法利用已建立的日本血吸虫病人血清库和其它寄生虫阳性血清制备测试用质控血清,分别对IHA试剂盒的敏感性、特异性、稳定性等相关指标进行综合评价。结果 IHA试剂盒敏感性、特异性较高,分别为97.33%和97.00%,约登指数为0.94;与肺吸虫、华支睾吸虫、旋毛虫、囊虫病人血清的交叉反应率分别为6.67%、6.67%、33.33%和6.67%。正常保存条件下,试剂盒有效期内的稳定性良好。结论湖北省生产的血吸虫病间接血凝(IHA)试剂盒敏感性、特异性、稳定性均较好,适用于疫区大规模病人筛查。
Objective To evaluate the sensitivity, specificity and stability of the Indirect Hemagglutination Test (IHA) kit developed by Hubei Province for schistosomiasis japonica. Methods The quality control serum was prepared by using the established serological library of schistosoma japonicum and other parasite-positive sera. The sensitivity, specificity and stability of the IHA kit were evaluated respectively. Results The sensitivity and specificity of the IHA kit were 97.33% and 97.00%, respectively, and the Youden index was 0.94. The cross-reactivity rates with the serums of paragonimiasis, Clonorchis sinensis, Trichinella spiralis and cysticercosis were 6.67 %, 6.67%, 33.33% and 6.67%. Under normal storage conditions, the stability of the kit during the valid period is good. Conclusion The indirect hemagglutination (IHA) kit of schistosomiasis produced in Hubei Province has good sensitivity, specificity and stability and is suitable for large-scale screening of patients in epidemic areas.