首页|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

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

扫码查看
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.
Methodology comparison of total IgE and allergen-specific IgE antibodies detection by nanomagnetic particle chemilumines-cence method
Objective To compare the clinical performance of a nano magnetic particle chemiluminescence method(BioCLIA®)for al-lergen 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 chemilumines-cence allergen detection platform has high consistency with ImmunoCAP system and less sample consumption.As a full quantitative al-lergen detection method it is worthy to be recommended to promote the application in clinical diagnosis.

allergen IgE antibodycomparison of methodologymagnetic particle chemiluminescenceallergen detection

吴叶丽、闵权、姚煦

展开 >

中国医学科学院&北京协和医学院皮肤病医院过敏与风湿免疫科,南京 210042

过敏原IgE抗体 方法学比对 纳米磁微粒化学发光法 过敏原检测

2024

临床检验杂志
江苏省医学会

临床检验杂志

CSTPCD
影响因子:0.746
ISSN:1001-764X
年,卷(期):2024.42(3)
  • 18