采用酶联免疫捕获法检测过敏原特异性IgE抗体的性能评价  

Performance evaluation of allergen specific IgE antibodies measurement using capture enzyme linked immunosorbent assay

作　　者：王瑞琦[1] 尹佳[1] 

机构地区：[1]中国医学科学院北京协和医学院北京协和医院变态反应科,100730

出　　处：《中华检验医学杂志》2016年第11期824-828,共5页Chinese Journal of Laboratory Medicine

摘　　要：目的对采用酶联免疫捕获法的符克？系统用于检测常见吸入物过敏原特异性IgE抗体（sIgE）进行性能评价。 方法 参考CLSI EP方案，对符克？系统进行性能评价。用符克？系统检测户尘螨、粉尘螨、猫毛屑、狗毛屑、链格孢、艾蒿花粉6种常见吸入物过敏原sIgE，评估其精密度、灵敏度、线性范围等，并与ImmunoCAP？系统进行比对，比对样本来源于2016年5月25日至6月30日门诊患者血清792份，对定量结果进行线性回归分析，对定性结果进行Kappa一致性分析。 结果符克？系统检测户尘螨、粉尘螨、猫毛屑、狗毛屑、链格孢、艾蒿花粉sIgE的批内CV%为3.60%～6.53%，总CV%为3.57%～7.46%，均小于试剂盒标示不精密度。定量测定下限均小于0.35 KU/L，低于厂商标示灵敏度。户尘螨sIgE的线性范围0.37～94.30 KU/L（R2＝0.999，P〈0.001），链格孢sIgE的线性范围0.35～89.80 KU/L（R2＝0.998，P〈0.001），线性相关均良好。符克？系统与ImmunoCAP？系统比较，定量结果有明显的直线相关性，户尘螨、粉尘螨、猫毛屑、狗毛屑、链格孢、艾蒿花粉的R2分别为0.356、0.473、0.847、0.478、0.254和0.355，P值均〈0.001；定性结果的阴性符合率、阳性符合率、总体符合率分别为99.2%（944/952），82.1%（528/643），92.3%（1 472/1 595），有高度一致性（Kappa＝0.835，P〈0.001）；分级一致率91.5%（1 459/1 595）。 结论 符克？系统是国产自动化全定量过敏原sIgE检测系统，具有较高的精密度和灵敏度，与ImmunoCAP？系统比较相关性良好，可满足临床检测要求，具有实用价值，为临床应用提供了新的选择。ObjectiveTo evaluate the performance of common inhalant allergen specific IgE antibodies （sIgE） measurement using capture enzyme-linked immunosorbent assay （ELISA）, Fooke？ system. MethodsThe performance of Fooke？ system was evaluated according to the CLSI EP documents. Specific IgE to 6 common inhalant allergens, Dermatophagoides pteronyssinus （d1）, Dermatophagoides farina （d2）, cat epithelium and dander （e1）, dog epithelium and dander （e5）, Alternaria Alternata （m6） and mugwort pollen （w6）, were measured by Fooke？ system. The precision, sensitivity, and linearity range were assessed. The results were compared with ImmunoCAP？ system, collecting the compared samples from clinical patient serum from 25 May 2016 to 30 June 2016. ResultsThe within run CVs of the 6 allergens were 3.60%-6.53%, and total CVs were 3.57%-7.46%, lower than the stated. Limit of quantitative determination was 〈0.35 KU/L, lower than the sensitivity stated. The linearity range of d1 and m6 was 0.37-94.30 KU/L （R2=0.999, P〈0.001） and 0.35-89.80 KU/L （R2=0.998, P〈0.001）, which demonstrated a sound linear correlation.In the method comparison tests, the quantitative results between Fooke？ and ImmunoCAP？ system had obvious linear correlation, R2 of d1, d2, e1, e5, m6 and w6 was 0.356, 0.473, 0.847, 0.478, 0.254 and 0.355, respectively, P〈0.001. The negative, positive and overall agreement ratio of qualitative results was 99.2% （944/952）, 82.1% （528/643） and 92.3% （1 472/1 595）, with high level of agreement （Kappa=0.835, P〈0.001）. The ranked agreement ratio was 91.5% （1 459/1 595）. ConclusionsFooke？ system （Capture ELISA） is domestically produced, automated and quantitative allergen sIgE detecting system, which showed high precision and sensitivity, and sound correlation with ImmunoCAP system, meeting the testing requirement. Fooke system has practical value, which is a new option for clinical application.

关 键 词：变应原 免疫球蛋白E 酶联免疫吸附测定 免疫酶技术 

分 类 号：R446.6[医药卫生—诊断学] R593.1[医药卫生—临床医学]