两种白喉IgG抗体酶联免疫吸附试验检测试剂的比较

Comparison of two test kits for IgG antibody against diphtheria

目的比较两种白喉IgG抗体酶联免疫吸附试验(ELISA)检测试剂Virion/Serion和亿特的检测性能。方法采用两种试剂检测61份2-7岁健康儿童血清和白喉抗毒素国际标准品10/262(ISDT10/262),比较试剂的定性和定量检测能力。结果检测血清标本白喉IgG抗体时,两种试剂定性检测结果的一致性为93.44%(Kappa=0.81,P=0.625);定量检测结果呈正相关(r=0.87,P<0.05),中、低浓度标本的定量检测结果具有良好的一致性。对比检测ISDT10/262时,Virion/Serion、亿特试剂检测值与ISDT10/262浓度值的平均比值分别为123.5%、94.5%,变异系数分别为6.3%、4.8%。结论两种试剂定性、定量检测能力相当,亿特试剂更适用于人群白喉抗体水平调查,Virion/Serion更适用于抗体阳转率检测。

Objective To compare the capability of two ELISA kits (Virion/Serion and Yite)for testing diphtheria IgG antibody.Methods We used the two kits to test 61 serum samples from 2-7-year-old healthy children andan international standard for diphtheria toxin 10/262(ISDT 10/262) for a qualitative and quantitative evaluation of test capabilities.Results In serum sample tests,the consistency rate of the qualitative results between the two kits was 93.44%(Kappa =0.81,P =0.625);the quantitative results showed a positive correlation (r=0.87,P <0.05),and the quantitative results for serum samples with low and medium antibody concentration showed better consistency.In ISDT 10/262 tests, the average ratios of concentrations by Virion/Serion and Yite kits to corresponding concentrations of ISDT 10/262 were 123.5% and 94.5%,with coefficients of variation of 6.3% and 4.8%,respectively. Conclusions The two test kits were comparable qualitatively and quantitatively.Yite is better for survey of diphtheria antibody levels among healthy populations,while Virion/Serion is better for detection of diphtheria antibody seroconversion.