我国几种日本血吸虫病免疫诊断试剂的综合测评

Comprehensive evaluation of several diagnosis agents of schistos omiasis japonica in China

目的 了解我国血吸虫病防治工作中使用的免疫诊断试剂的综合质量,为第三次全国血吸虫病流行病学抽样调查查病工具的筛选提供参考。方法 聘请血吸虫病免疫诊断及相关专家组成专家评估组,确定综合测评指标。采用单盲法,由各日本血吸虫病免疫诊断试剂的生产单位对2 5 4份血清统一进行测试。计算各试剂盒的敏感性、特异性、Youden指数,收集其他测评指标的相关信息并进行分析。结果 参评的8个研究所(公司)的9种试剂盒总体上质量较好,大部分试剂盒的敏感性或特异性在90 %以上,其中Youden指数在0 .9以上的试剂盒有3个,但并殖吸虫病的交叉反应普遍存在,乙型肝炎的交叉反应在0～30 %之间。由于操作以及结果判断失误等其他原因,个别试剂盒的测试结果不够理想。结论 参加测评的绝大部分试剂盒的敏感性和特异性都达到了现场应用标准。

Objective To evaluate the compr ehensive quality of the immuno-diagnsosis reagents applied in schistosomiasis p r evention and control in China and to supply information for selection of disease detection reagents in the third national schistosomiasis epidemiological sampli ng survey. Methods Seven relevant experts in im muno-diagnosis on schistosomiasis were invited as members of an evaluation grou p, which determined comprehensive evaluation indexes. A total of 254 sera were examined with the single-blind method by the professionals fro m the immuno-diagnosis reagent producers. Specificity, sensitivity, Youden inde x and information of other relevant comprehensive indexes were investigated and ana lyzed. Results The qualities of 9 reagents prod uced b y 8 units were relatively good. The sensitivity or specificity was above 90% in most reagents, and Youden index was above 0.9 in 3 reagents. However, cross rea c tions with sera of paragonimiasis patients were general and 0-30% cross reactio n with sera of hepatitis B patients were present in some of reagents. Conclusion Most reagents tested in this evaluation can be used in schistosomiasis control and prevention.