日本血吸虫间接血凝法抗体检测试剂盒稀释液的改进

目的  确定一种适用于安徽安吉医药科技有限公司新包装试剂盒的稀释液，替代原包装中的冻干致敏红细胞稀释液（生理盐水）和血清标本稀释液（蒸馏水）。 方法  以pH7.2磷酸盐缓冲液作为稀释液制备新包装试剂盒替代原包装，比较新包装试剂盒与原包装的敏感性和特异性以及与肝吸虫、肺吸虫、姜片虫和钩虫等病人血清交叉反应情况；比较各试剂盒的最低检出量，观察凝集反应模式。 结果  新包装试剂盒与原包装敏感性分别为95%和94.2%，差异无统计学意义（χ2=0.000，P=1.000）；特异性分别为96.9%和95.8%，差异无统计学意义（χ2=0.000，P=1.000）；约登指数分别为0.92和0.9；最低检出量均为1:1 280，磷酸盐缓冲液组凝集模式较好；与肝吸虫、姜片虫和钩虫病人的血清交叉反应率均为0，与肺吸虫的交叉反应率均为19.4%。 结论  确定磷酸盐缓冲液作为日本血吸虫间接血凝法抗体检测试剂盒新包装的稀释液，替代原包装中的致敏红细胞稀释液和标本稀释液。

Alternative diluent used for the commercial IHA assay kit for detection of Schistosoma japonicum anti-body

Objective To evaluate the feasibility of a new diluent as a substitute for the original ones（saline used for diluting the lyophilized sensitized red cells,and distilled water for diluting the serum specimen）packaged in the commercial indirect hemagglutination（IHA）assay kit manufactured by Anhui Anji Pharmaceutical Technology Co.,Ltd.Methods Phosphate buffered solution（PBS,pH7.2）was used to replace the diluent in the original kit,and two preparations were compared regarding the sensitivity and specificity in detection of Schistosoma japonkum as well as the cross—reactivity with liver fluke,lung fluke,giant intestinal fluke and hookworm.The minimal quantification and the agglutination pattern in each group were also observed.Results The sensitivity and specificity were 95%and 96.9%for the modified kit,94.2%and 95.8%for the original one,which suggested no significant difference（x^2=0.000,P=1.000）.The Youden index were 0.92 and 0.9,respectively,and the minimum detectable amount was equal 1：1 280 to the two kits.However,PBS led to favorable agglutination pattern.The cross-reactivity rate with liver fluke,giant intestinal fluke and hookworm was0 and 19.4%with the lung fluke.Conclusion It is feasible to replace the diluent in original kit with PBS as dilution for the modified IHA kit.