自制捕获法ELISA抗麻疹病毒-IgM诊断试剂盒的初步评价

The preliminary evaluation of the self-established capture ELISA anti-measles virus （MV） specific IgM kit

目的初步评价应用自制抗麻疹病毒（抗MV）单克隆抗体（McAB；单抗）及其酶结合物研制的捕获法ELISA抗MV-IgM诊断试剂盒。方法考核本试剂盒的特异性和稳定性；比较其与同类商品试剂盒的临床检测结果，以评估检测血清抗MV-IgM的敏感性。结果①本试剂盒仅与抗MV-IgM阳性血清发生反应，而与抗甲型肝炎病毒-IgM（抗HAV-IgM）、抗乙型脑炎病毒-IgM（抗JEV-IgM）、抗乙型肝炎病毒核心-IgM（抗HBc-IgM）、抗巨细胞病毒-IgM（抗CMV-IgM）、抗EB病毒-IgM（抗EBV-IgM）及类风湿因子（RF）阳性血清均无反应；试剂盒放置37℃ 3d，检测血清抗MV-IgM的活性，无明显降低。②在39例临床疑似麻疹的56份血清中，两种试剂盒仅对8例的8份血清抗MV-IgM检测结果不一致，其中6例的首份血清，本试剂盒阳性，商品试剂盒阴性（第2份血清两种试剂盒均阳性），1例的首份血清（未采到第2份血清），本试剂盒为临界值，商品试剂盒阴性。另1例的第2份血清本室试剂盒阳性，商品试剂盒阴性（两种试剂盒首份血清均阴性，第3份血清均阳性）。结论本实验室研制的捕获法ELISA抗MV-IgM诊断试剂盒具有良好的特异性、稳定性和敏感性，适于麻疹病毒感染的临床诊断和流行病学监测。

Objective To evaluate the self-established capture ELISA anti-measles virus （MV） specific IgM kit developed by using anti-MV monoclonal antibody （McAb） prepared in this laboratory. Methods The specificity, stability of this kit were tested and its sensitivity were assessed by comparing the detected results of anti MV-IgM in sera of cases with suspected measles using this kit and the same type commercial kit. Results （1）This kit is only able to react with serum positive for anti-MV specific IgM and unable to react with serum positive for anti HAV-IgM, anti JEV-IgM, anti HBc-IgM, anti CMV-IgM, anti EBV-IgM and RF; No significant decrease was observed in activity of detecting anti MV IgM by this kit stored at 37℃ for 3 days. （2）The results detecting anti MV IgM by this kit were inconsistent with that by the same type commercial kit in 8 sera of 8 cases among 56 sera of 39 cases with suspected measles. In these 8 sera, 6 first sera of 6 cases were positive by this kit and negative by the commercial kit （6 second sera of same cases were positive by both kits）; 1 first serum was positive by this kit and negative by the commercial kit （no second serum of the same case was obtained）; 1 second serum was positive and negative by the commercial kit （first serum was negative and third serum was positive by both kits）. Conclusion The specificity, stability and sensitivity of this capture ELISA anti-MV specific IgM kit developed by this laboratory are good and suitable for clinical laboratory diagnoses and epidemiological surveillance.