间接ELISA法检测柯萨奇B组病毒感染的特异性IgM抗体诊断试剂盒的研制

THE INDIRECT ELISA DIAGNOSTIC KIT FOR DETECTING COXSACKIE B VIRUS SPECIFIC IgM

用抗原纯化和吸收剂处理患儿血清的方式，对已建立的间接酶联免疫吸附测定（ＥＬＩＳＡ）检测柯萨奇Ｂ组病毒（ＣＢＶ）－ＩｇＭ方法进行了改进，在确定其特异性、敏感性和可靠性的基础上，做了主要试剂的稳定性和抗破坏性试验证实符合商品试剂盒要求。２３７例病毒性心肌炎和４１例Ｉ型糖尿病患者血清经检测阳性率分别为３３．３％和５６．１％。本方法的阳性预测值为８０％，阴性预测值为１００％，变异系数小于１１．１％。主要试剂４℃保存半年或３７℃保存一周均对标本的检测结果无显著影响。

We have improved indirect ELISA that was established for detection IgM of CBV by purifying the antigen and treating the sera with adsorbentOn the basis of determining the specificity, sensitivity,reliability of the method, we did the stability and antidestruction test of the main reagents The experiment results meet the requirements of commercial reagent kit237 children with viral myocarditis and 41 patients with IDDM were tested,the positive rate were 333% and 561% respectively The positive predictive value is 80% ,negative predictive value 100%,coefficient of variation ≤111% It is no signficant influence on the detection results when they were stored main reagents in 4℃ for 6 months or in 37℃ for one week Clinical use in many hospitals has showed that our method is reliable for diagnosing early infection of CBV