麻疹IgG抗体定量检测酶联免疫吸附试验试剂的比较和评价

Comparison and Evaluation of Enzyme-linked Immunization Assay Kits with Plague Reduction Neutralization Test for Detection of Measles IgG Antibody

目的对目前中国市场上已有的两种麻疹IgG抗体定量检测酶联免疫吸附试验(Enzyme-linked Immunosorbent Assay,ELISA)试剂(德国Virion/Serion试剂和德国IBL试剂)进行比较和评价,筛选适用于2006年全国人群麻疹血清流行病学调查的试剂。方法以蚀斑减少中和试验(Plague Reduction Neutralization Test,PRNT)的检测结果为"金标准",分别用两种ELISA试剂检测52份麻疹IgG抗体组合血清,然后对试剂的定性和定量能力进行全面分析和评价。结果两种ELISA试剂均能正确的将13份PRNT结果为阴性的血清判定为阴性,特异度均为100%。两种试剂中,Virion/Serion试剂的敏感度为94.9%,与PRNT结果的相关性Kappa值为0.902,相关系数为0.878(P<0.01);IBL试剂敏感性为58.8%,与PRNT结果的相关性Kappa值为0.441,相关性系数为0.850(P<0.01)。结论Virion/Serion试剂的特异性、敏感性较好,有单孔IgG抗体定量能力,价格适中,适于在自动化工作平台工作站中开展大规模血清样本的检测。

Objective To evaluate and comparison of 2 commercial ELISA kits （Vrion/Serion kit and IBL kit） which ELISA kit will be used in sero-epidemiological survey in China in 2006 by Plaque Reduction Neutralization Test （PRNT）. Methods 52 serum panel which contain different levels of measles antibody were used. Results The results showed that the sensitivity, PPV and accurate of Virion/Serion kit achieved highest score when taking PRNT as ＂gold standard＂. Virion/Serion kit showed good relationship with PRNT titer： the correlation coefficients are 0.878 （P〈0.01）. IBL kit get lower correlation coefficients 0.850 （P〈0.01）. The test value and mean of unit of serum antibody increased along with neutralizing titers increased. Conclusion The Virion/Serion kit is good in sensitivity and specificity. It has quantitative for single well. The kit is suitable for sera epidemiology survey to detection of automatic workstation in China.