儿童总免疫球蛋白E和特异性免疫球蛋白E临床可报告范围建立的研究  

A Study of Establishing the Clinical Reportable Range of Total Immunoglobulin E and Specific Immunoglobulin E in Children

作　　者：张旭东 刘永革[1] 任亦欣[1] 姜楠楠 向莉[1] 宋文琪[2] ZHANG Xudong;LIU Yongge;REN Yixin;JIANG Nannan;XIANG Li;SONG Wenqi(Department of Allergy,National Clinical Research Center for Respiratory Diseases,Key Laboratory of Major Diseases in Children,Ministry of Education,Beijing Children’s Hospital,Capital Medical University,National Center for Children’s Health,Beijing 100045 China;Department of Clinical Laboratory Center,Beijing Children’s Hospital,Capital Medical University,National Center for Children’s Health,Beijing 100045,China)

机构地区：[1]国家儿童医学中心首都医科大学附属北京儿童医院儿科重大疾病研究教育部重点实验室国家呼吸系统疾病临床医学研究中心过敏反应科,北京100045 [2]国家儿童医学中心首都医科大学附属北京儿童医院检验中心,北京100045

出　　处：《标记免疫分析与临床》2022年第5期852-856,共5页Labeled Immunoassays and Clinical Medicine

基　　金：国家呼吸系统疾病临床医学研究中心呼吸专项(编号:HXZX-20210203)。

摘　　要：目的建立儿童荧光酶联免疫分析法检测总免疫球蛋白E(tIgE)和特异性免疫球蛋白E(sIgE)的临床可报告范围。方法收集儿童tIgE和sIgE血清样本12例,参考中国合格评定国家认可委员会(CNAS)和美国临床实验室标准化协会(CLSI)相关文件,在荧光免疫分析仪上进行tIgE和sIgE的分析测量范围(AMR)验证试验,建立其临床可报告范围(CRR)。结果tIgE的AMR为3~4788kU/L,最大允许稀释倍数为50倍,CRR为3~239400kU/L。sIgE的AMR为0.01~92.97kUA/L,不能进行稀释,CRR为0.01~92.97kUA/L。结论儿童tIgE和sIgE临床可报告范围的建立,对于高值病例的动态监测和病例间比较有重要意义,tIgE能够满足临床需求。Objective To establish the clinical reportable range of total immunoglobulin E(tIgE)and specific immunoglobulin E(sIgE)in children by fluorescence enzyme immunoassay.Methods Serum tIgE and sIgE samples were collected from 12 children,referring to relevant documents of China National Accreditation Service for Conformity Assessment(CNAS)and American Association for Clinical Laboratory Standardization(CLSI).The analytical measurement range(AMR)validation tests of tIgE and sIgE were carried out on Phadia1000 fluorescence immunoassay analyzer to establish the clinical reportable range(CRR).Results AMR of tIgE was 3-4788 kU/L with a maximum permissible dilution ratio of 50 times,and CRR was 3-239400 kU/L.SIgE AMR was 0.01-92.97KUA/L,of which dilution step was not recommended,and CRR was 0.01-92.97kUA/L.Conclusion The establishment of tIgE and sIgE clinical reportable range in children is of great significance for the dynamic monitoring and inter-case comparison of high-value cases,and tIgE can meet the clinical needs.

关 键 词：总免疫球蛋白E 特异性免疫球蛋白E 临床可报告范围 荧光酶联免疫分析法 

分 类 号：R-331[医药卫生]