代 苗1，吴荣桂2，朱玉青3，李 娜2，吴 斌2，季纯宇4，王 健2，秦 枫2*
（1.三六三医院，四川成都 610097；
2.四川携光生物技术有限公司，四川成都 611730；
3.河南省医疗器械检验所，河南郑州 450003；
4.成都大学附属医院血液科，四川成都 610081）
摘要：随着全球食物过敏发生率的逐年升高，食物过敏性疾病已成为人们日益关注的食品安全和公共卫生问题。本实验依据中华人民共和国医药行业标准YY/T 1581-2018，分析了磁微粒化学发光法定量检测过敏原特异性IgE抗体试剂盒产品性能及特点；并就主要食物类过敏原牛奶、鸡蛋、蟹、虾和小麦等5个重点项目与ImmunoCAP过敏原检测系统的检测结果进行了一致性评价。结果显示，该试剂盒检测方法的分析内精密度（CV）＜4%，分析间精密度＜7%；检出限≤0.10 IU/mL，在0.10～100.00 IU/mL的检测范围内，检测方法的相关系数≥0.990 0；其准确度、特异性等各项指标均满足行业标准的要求。所选5个食物过敏原重点项目与ImmunoCAP检测系统比对，阴阳性符合率＞90%，Kappa值＞0.75。实验所用的过敏原特异性IgE抗体定量检测试剂盒分析性能优良，符合过敏原抗体检测的需求，与ImmunoCAP过敏原检测系统检测结果一致性良好，具有很高的推广价值。
关键词：纳米磁微粒；化学发光；食物过敏原；过敏原特异性IgE抗体；定量检测
中图分类号：TS207.3 文献标识码：A 文章编号：1674-506X（2021）06-0120-0004
Evaluation of Quantitative Detection of Food Allergen Specific IgE Antibody by Chemiluminescence
DAI Miao1, WU Rong-gui2, ZHU Yu-qing3, LI Na2, WU Bin2, JI CHUN-yu4, WANG Jian2, QIN Feng2*
（1.363 Hospital, Chengdu Sichuan 610097, China;
2.Sichuan C-Luminary Biotech Co., Ltd., Chengdu Sichuan 611730, China;
3.Henan Institute for Medical Device Inspection, Zhengzhou Henan 450003, China;
4.Department of Hematology, Affiliated Hospital of Chengdu University, Chengdu Sichuan 610081, China）
Abstract：As the incidence of global food allergies increases year-by-year, food allergic diseases have become a growing concern in food safety and public health issue circles. In this paper, according to YY/T 1581-2018 pharmaceutical industry standard of the People’s Republic of China, the performance and characteristics of the kit for quantitative detection of allergen specific IgE antibody by magnetic particle chemiluminescence were analyzed; Five key items of food allergens including milk, egg, crab, shrimp and wheat were evaluated for consistency with Immuno CAP's detection system. The results showed that the intra-analytical precision (CV) of the kit was less than 4% and the inter-analytical precision was less than 7%. The detection limit was ≤0.10IU/mL, and the correlation coefficient was ≥0.990 0 within the detection range of 0.10～100.00 IU/mL; Its accuracy, specificity and other indicators meet the requirements of industry standards. Compared with ImmunoCAP allergen detection system, the coincidence rate of negative and positive was ＞90%, and Kappa value was ＞0.75. The quantitative detection kit for allergen specific IgE antibody has good analytical performance and meets the needs of clinical application. It has good consistency with the detection results of Immuno CAP allergen detection system, and has high clinical application and promotion value.
Keywords：magnetic nanoparticles; chemiluminescence; food allergen; specific IgE antibody; quantitative detection
doi：10.3969/j.issn.1674-506X.2021.06-020
收稿日期：2021-09-28
作者简介：代苗（1989-），女，本科，护师。研究方向：胃肠胸外科；吴荣桂（1993-），男，本科。研究方向：体外诊断试剂研发。
*通信作者
引文格式：代苗,吴荣桂,朱玉青,等.化学发光法定量检测食物过敏原特异性IgE抗体性能研究[J].食品与发酵科技,2021,57(6):120-123.
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