过敏原特异性IgE抗体定量检测试剂的性能验证

Performance verification for allergen specific IgE antibody quantitative detection reagents

目的对某品牌过敏原IgE抗体定量检测试剂进行性能验证。方法参考美国临床和实验室标准协会(clinical and laboratory standards institute,CLSI)及中华人民共和国医药行业标准YY/T 1581-2018的相关文件,对符博克TM过敏原IgE抗体定量检测试剂进行准确度、检出限、线性、重复性、批间差、特异性验证,并与ImmunoCAP系统检测结果进行一致性评价。结果该试剂批内变异系数(CV)<10%,批间CV<20%,与WHO 11/234标准品的相对偏差<15%,回收率为85%~115%,检出限≤0.35 IU/mL,稀释线性相关系数>0.99,对总IgE浓度>60 IU/mL的样本、IgA浓度>700μg/mL的样本、IgM浓度>500μg/mL的样本、IgG浓度>7000μg/mL的样本的测定浓度均不高于检出限(0.35 IU/mL)。与ImmunoCAP系统进行方法学比对,屋尘螨、粉尘螨、屋尘、艾蒿、鸡蛋、牛奶6个项目Kappa值均>0.75。结论该过敏原特异性IgE抗体的定量检测试剂具有良好的准确度、检出限、线性、重复性、批间差、特异性,与ImmunoCAP系统具有较高的一致性,具备临床推广价值。

Objective To verify the performance of a brand of allergen IgE antibody quantitative detection reagents.Methods According to the relevant documents of Clinical and Laboratory Standards Institute(CLSI)and pharmaceutical industry standards of the People′s Republic of China YY/T 1581-2018,the accuracy,detection limit,linearity,repeatability,inter-assay variation and specificity of HOBTM allergen IgE antibody quantitative detection reagents were verified,and the consistency was evaluated by comparing with the results of the ImmunoCAP system.Results The intra-assay coefficients of variation(CV),inter-assay CV,recovery,detection limit and linear correlation coefficient of the reagents were<10%,<20%,85%-115%,≤0.35 IU/mL and>0.99,respectively.The relative deviation between the reagents and WHO 11/234 standard mateirals was below 15%.When the samples with total IgE>60 IU/mL,IgA>700μg/mL,IgM>500μg/mL or IgG>7000μg/mL were detected by the reagents,the concentrations of allergen specific IgE antibody were not higher than the detection limit(0.35 IU/mL).Compared with the ImmunoCAP system,the Kappa values of 6 items,including dermatophagoides pteronyssinus,dermatophagoides farinae,house dust,mugwort,egg and milk,were higher than 0.75.Conclusion HOBTM allergen specific IgE antibody quantitative detection reagents have good accuracy,detection limit,linearity,repeatability,inter-assay variation and specificity,and have high consistency with the ImmunoCAP system,indicating that they have clinical application value.