两种高效液相色谱法糖化血红蛋白分析诊断产品性能参数的对比性研究  

The Performance Parameters Evaluation for Different Glycated Hemoglobin Diagnostic Reagents with High Performance Liquid Chromatography

作　　者：高智勇[1] 潘玥[1] GAO Zhiyong;PAN Yue(Department of Laboratory Medicine,Beijing Haidian Hospital,Beijing 100080,China)

机构地区：[1]北京市海淀医院检验科,北京100080

出　　处：《标记免疫分析与临床》2021年第1期137-143,173,共8页Labeled Immunoassays and Clinical Medicine

摘　　要：目的探讨两种高效液相色谱法糖化血红蛋白诊断试剂的性能参数的差异性,为临床应用选择合适的诊断试剂提供参考依据。方法选取日本TOSOH CORPORATION生产的高效液相法糖化血红蛋白诊断试剂(糖化血红蛋白层析柱、洗脱缓冲液和溶血洗净液)和世瑞纳科(天津)医疗科技有限责任公司生产的高效液相法糖化血红蛋白诊断试剂(糖化血红蛋白分析用洗脱液、糖化血红蛋白溶血剂和糖化血红蛋白层析柱),在TOSOH HLC-723G8型全自动糖化血红蛋白分析仪上进行准确性、批内精密度、批间精密度、日内及日间精密度、携带污染率、线性、相关性等性能参数分析,以评估两生产厂家试剂性能参数之间的差异性。结果两公司试剂产品性能参数:准确度检测结果相对误差均<±6%;批内精密度变异系数均<3.0%;批间精密度变异系数均<3.0%;新鲜抗凝全血样本日内精密度的精密度均<1.45%;糖化血红蛋白质控品的日间精密变异系数均<2.0%。携带污染率结果均<1.0%;检测结果的相关系数为0.9973,R 2>0.990。结论上述两公司产品的主要性能参数:准确性、精密度、携带污染率和线性均满足临床检测要求,两产品间具有良好相关性。Objective To evaluate two types of glycated hemoglobin diagnostic products performance parameters for providing a reference for the selection of appropriate diagnostic reagent products.Methods High performance liquid chromatography diagnostic reagent products for glycated hemoglobin(column elution buffer,and hemolytic washing solution)were made in TOSOH CORPORATION in Japan and Lirimax(Tianjin)Medical Technology Co.,Ltd and were performed on TOSOH HLC-723G8 automatic glycated hemoglobin analyzer for accuracy,batch precision,and batch-to-batch analysis of performance parameters,including precision,within-day and within-day precision,carry-over pollution rate,linearity,and correlation,etc.,in order to evaluate the differences between the reagent products of the two manufacturers.Results The accuracy of relative errors and the national standard substance indicated value was less than±6%.The variation coefficient of within batch precision was less than 3.0%.The variation coefficient of between batch precision was less than 3.0%.The variation coefficient of within batch precision was less than 3.0%and the variation coefficient of within batch precision was less than 2.0%.The variation coefficient of intraday precision of within day precision was as following:fresh anticoagulant whole blood samples was less than1.45%.The variation of between day precision coefficient of glycosylated hemoglobin quality control was less than 2.0%.Carryover contamination rate was less than 1.0%.The correlation coefficient of the test results between the glycosylated hemoglobin reagent products of the two companies was 0.9973.Linear equation of TOSOH reagent products was as following:R 2≥0.990(P<0.001).Conclusion Through the analyses of the accuracy,precision,carryover contamination rate,linearity and other relevant performance parameters,it is found that there is no significant difference between the performance parameters of Lirimax reagent products and TOSOH reagent products,and there is a fine correlation between the reagent product

关 键 词：高效液相色谱法 糖化血红蛋白 精密度 携带污染率 线性 

分 类 号：R446.1[医药卫生—诊断学]