血清tIgE竞争性光激化学发光定量检测方法的建立及应用  

Development and application of competitive light-initiated chemiluminescent assay for quantitation of total IgE in human serum

作　　者：边颖[1,2] 魏刚 李军普[1] 崔亚琼 魏殿军 李会强[1] 

机构地区：[1]天津医科大学医学检验学院,天津300203 [2]天津医科大学第二医院检验科,天津300211 [3]天津医科大学总医院检验科,天津300052

出　　处：《临床检验杂志》2018年第1期1-4,13,共5页Chinese Journal of Clinical Laboratory Science

基　　金：国家自然科学基金面上项目(81772259)

摘　　要：目的基于光激化学发光分析(LICA),采用竞争免疫分析模式建立血清总免疫球蛋白E(tIgE)的定量检测方法。方法将抗人IgE抗体包被发光微球,生物素标记人IgE纯品,与血清原液(标准品)及包被有链霉亲合素的感光微球构成完整的分析体系,并对该方法进行条件优化、性能评估和相关性分析。结果本方法的重复性、期间精密度分别为5.50%~7.73%和6.45%~9.90%;功能灵敏度为12.65 IU/mL;回收试验回收率在104.15%~109.37%之间;总胆红素、血红蛋白、三酰甘油对不同浓度tIgE样本的干扰率在-4.49%~8.46%之间;在临床111例血清标本tIgE的检测中,该方法与Beckman Coulter IMMAGE 800免疫透射比浊法具有良好的相关性(r2=0.959)。结论本研究建立的血清tIgE定量检测方法性能良好,可满足临床应用的基本要求。Objective To develop a competitive immunoassay for quantitative determination of total immunoglobin E （tIgE） in human serum based on light-initiated chemiluminescent assay （LICA）. Methods The LICA-tIgE assay was performed by incubating serum samples or calibrator with anti-human IgE antibody-coated chemiluminescet beads, biotinylated human IgE and streptavidin-coated sen- sitizer beads. The working conditions of this assay were optimized, analytical performance was detected and the correlation of tIgE re- sults between LICA and Beckman Coulter IMMAGE 800 was evaluated. Results The precision of intra-assay and inter-assay （ coeffi- cient of variation） ranged from 5.50% to 7.73% and 6.45% to 9.90%, respectively. The functional sensitivity of this assay was 12.65 IU/mL. The recovery rates measured by adding IgE calibrators to human sera with different IgE concentrations were ranged from 104.15% to 109.37%. The disturbing rates measured by adding total bilirubin, hemoglobin and triacylglycerol to human sera with dif- ferent IgE concentrations were ranged from -4.49% to 8.46%. Also, the tIgE results of 111 patients measured by LICA correlated well with those by Beckman Coulter IMMAGE 800 （ r2 = 0. 959）. Conclusion LICA developed in this study for detecting tIgE of hu- man serum showed effective performance and could meet the basic requirements of clinical diagnostic reagents.

关 键 词：总免疫球蛋白E 光激化学发光分析 均相免疫分析 竞争性分析 定量分析 

分 类 号：R446.6[医药卫生—诊断学]