CLSI EP12-A2和EP15-A2在磁微粒化学发光法肺炎支原体IgM抗体检测试剂性能评估中的应用

Application of CLSI EP12-A2 and EP15-A2 in the performance evaluation of M.pneumoniae IgM by CLIA microparticles

目的应用美国临床和实验室标准协会EP12-A2和EP15-A2文件,评估一种磁微粒化学发光法肺炎支原体IgM抗体检测试剂的性能。方法参照EP15-A2文件,选用高、中、低3个浓度的样本,每个样本4次/d测定,持续5 d,计算总不精密度。根据EP12-A2文件,制备C50、C50-20%、C50+20%浓度样本,重复检测40次,验证C50±20%是否在C5~C95区间之外;并选择郑州儿童医院792份样本,分别与被动凝集法和ELISA法进行方法学比对,计算符合率和Kappa值。结果高、中、低3个浓度样本的总不精密度均<6%,优于行业标准和说明书声称值。3批产品的C50±20%均在C5~C95区间之外,验证通过。磁微粒化学发光法与被动凝集法的阳性符合率为95.8%,阴性符合率为96.9%,Kappa值为0.893;ELISA法的阳性符合率为97.4%,阴性符合率为98.9%,Kappa值为0.956。结论磁微粒化学发光法肺炎支原体IgM抗体检测试剂精密性良好,与被动凝集法和ELISA法的符合率较好,性能满足临床要求。

Objective To assess the application of CLSI EP12-A2 and EP15-A2 in the performance evaluation of M.pneumoniae IgM by CLIA microparticles.Methods Referring to the EP15-A2 method,three samples with high,medium,and low concentrations of M.pneumoniae IgM were selected.Each sample was detected 4 times per day for 5 days,and the total imprecision CV was calculated.Referring to the EP12-A2 method,samples of C50,C50-20%and C50+20%were prepared and repeated 40 times to verify that C50±20%bounded the C5-C95 interval.A total of 792 samples from Zhengzhou Children’s Hospital were compared with the passive agglutination method and the ELISA method,the coincidence rates and Kappa values were calculated.Results The total imprecision CV was less than 6%,lower than the industry standard and manufacture announcement.C50±20%concentration fell outside the C5-C95 interval.Compared with passive agglutination method,the positive coincidence rate was 95.8%,the negative coincidence rate was 96.9%,Kappa value was 0.893;compared with the ELISA method,the positive coincidence rate was 97.4%,the negative coincidence rate was 98.9%,Kappa value was 0.956.Conclusion The performance of M.pneumoniae IgM by CLIA microparticles can meet clinical requirements.