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.
作者
李静静
王雪琦
孙娅顺
赵思琪
刘春龙
钟成
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)
出处
《中国免疫学杂志》
CAS
CSCD
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)。
