基于化学发光免疫技术检测念珠菌IgG抗体方法的建立与性能评估  

Establishment and performance evaluation of a chemiluminescence immunoassayfor detecting Candida IgG antibody

作　　者：李静静 王雪琦 孙娅顺 赵思琪 刘春龙 钟成[1] LI Jingjing;WANG Xueqi;SUN Yashun;ZHAO Siqi;LIU Chunlong;ZHONG Cheng(School of Biological Engineering,Tianjin University of Science and Technology,Tianjin 300457,China;Tianjin Key Laboratory of Accurate Diagnostic Technology for Invasive Mycosis,Tianjin 300467,China)

机构地区：[1]天津科技大学生物工程学院,天津300457 [2]天津市侵袭性真菌病精准诊断技术企业重点实验室,天津300467

出　　处：《中国免疫学杂志》2024年第2期389-394,共6页Chinese Journal of Immunology

基　　金：天津市创新药物和医疗器械科技重大专项(19ZXYXSY00080)。

摘　　要：目的:基于化学发光免疫技术建立一种即时检测念珠菌甘露聚糖IgG抗体的方法。方法:依据间接法原理建立念珠菌甘露聚糖IgG抗体检测体系,并参照美国临床试验室标准化协会(CLSI)批准指南进行分析性能评估。结果:生物素标记念珠菌甘露聚糖抗原与碱性磷酸酶标记抗人IgG抗体工作液浓度均为1μg/ml;检测方法空白限为5.20 AU/ml;检出限为5.50 AU/ml;试剂精密度与重复性变异系数(CV)均<10%;检测方法与常见特异性抗体无交叉反应;血红蛋白、三酰甘油及胆红素对临床样本均无显著影响;检测方法与ELISA法总体符合率为90%,Kappa值=0.80,回归分析与偏差分析结果均表明两种方法有较强一致性(R2=0.9898)。结论:本研究所建立检测体系性能均符合临床辅助诊断技术相关要求,适用于血清样本中念珠菌甘露聚糖IgG抗体的快速检测。Objective:To establish a method for Point of Care Testing detection Candida mannan IgG antibody based on chemi-luminescence immunoassay.Methods:The candida mannan IgG antibody detection system was established according to the indirect method principle,and the analytical performance was evaluated according to the approved guidelines of the American Clinical Labora-tory Standardization Association(CLSI).Results:Biotinylated Candida mannan antigen and Alkaline Phosphatase-labeled IgG anti-body was successfully conjugated,and the optimal reaction concentration was 1μg/ml.The limit of blank was 5.20 AU/ml.The limit of detection was 5.50 AU/ml.The precision and repeatability of CV were less than 10%.There was no cross reaction between the detec-tion method and common specific antibodies.Hemoglobin,triglyceride and bilirubin had no significant effect on clinical samples.The overall coincidence rate between the detection method and ELISA were 90%,and the Kappa value=0.80,regression analysis and devi-ation analysis showed that the two methods had strong consistency(R2=0.9898).Conclusion:The performance of the strip chemilumi-nescence detection system established in this study meets the relevant requirements of clinical auxiliary diagnostic technology,and is suitable for the rapid detection of Candida mannan IgG antibody in serum samples.

关 键 词：念珠菌IgG抗体 化学发光免疫技术 性能分析 

分 类 号：R446.61[医药卫生—诊断学]