纳米磁微粒化学发光法临床检测总IgE抗体和过敏原sIgE抗体的方法学比对

Methodology comparison of total IgE and allergen-specific IgE antibodies detection by nanomagnetic particle chemiluminescence method

目的对纳米磁微粒化学发光法平台(纳博克)检测临床样本中的总IgE抗体和过敏原特异性IgE抗体进行方法学比对。方法参考美国临床和实验室标准协会的相关文件,针对总IgE抗体以及屋尘螨D1/粉尘螨D2/交链孢霉M6/蟑螂I6/猫上皮E1/艾蒿W6/牛奶F2/蛋白F1/小麦F4/虾F24/花生F13共计11项过敏原,对纳博克和ImmunoCAP系统的一致性采用卡方检验和Kappa检验进行比较及评价。结果11项过敏原两种方法学比对的Kappa值均>0.75,表明两种方法学具有较好的一致性。除了交链孢霉和小麦两项外,其余项目的阴性、阳性、总符合率和±1级符合率均在90%以上,表明两种方法学的定性一致性良好;Spearman相关系数(r)均位于95%置信区间(CI)内,表明两种方法学的量值具有显著相关性。结论纳博克纳米磁微粒化学发光法过敏原检测平台与ImmunoCAP系统具有良好的一致性,前者的样本用量更少,是一种建议临床推广使用的全定量过敏原检测方法学。

Objective To compare the clinical performance of a nano magnetic particle chemiluminescence method(BioCLIA)for allergen detection.Methods Referring to the relevant documents of the clinical and laboratory standards institute the total IgE and the allergen-specific IgE for 11 major allergen items,i.e.,Dermatophagoides farinae D1,Dermatophagoides farinae D2,Alternospora M6,\Cockroach I6,Cat Epithelium E1,Mugwort W6,Milk F2,Egg white F1,Wheat F4,Shrimp F24 and Peanut F13 were detected by BioCLIA and ImmunoCAP systems simultaneously.The consistency of the two methods was evaluated by chi-square and Kappa tests.Results The Kappa values of the 11 allergens were all>0.75,indicating good consistency between the two methods.The negative,positive,total coincidence rate and±1 grade coincidence rate were all above 90%except for Alternaria and wheat,indicating good qualitative agreement between the two methods.Spearman′s correlation coefficients were all within 95%confidence intervals,indicating that the quantity values of the two methodologies were significantly correlated.Conclusion BioCLIA magnetic particle chemiluminescence allergen detection platform has high consistency with ImmunoCAP system and less sample consumption.As a full quantitative allergen detection method it is worthy to be recommended to promote the application in clinical diagnosis.