国产高效液相色谱法试剂检测糖化血红蛋白主要性能研究  

A Study on Main Parameters Properties of Glycosylated Hemoglobin Detection Reagents

作　　者：罗金刚 王厚照 罗晓花 LUO Jingang;WANG Houzhao;LUO Xiaohua(Department of Laboratory Medicine,Xiang’an Hospital of Xiamen University,School of Medicine,Xiamen University,Xiamen 361102,China)

机构地区：[1]厦门大学附属翔安医院检验科,福建厦门361102

出　　处：《标记免疫分析与临床》2022年第12期2141-2146,共6页Labeled Immunoassays and Clinical Medicine

基　　金：厦门大学开放项目(编号:SKLVD2018KF008);福建省厦门市科技计划项目(编号:3502Z20199052)。

摘　　要：目的评估国产糖化血红蛋白检测产品的实验室分析性能。方法采用国产糖化血红蛋白检测试剂与全自动糖化血红蛋白分析仪组成测量系统,对检测系统的准确度、批内精密度、室内精密度、线性范围和携带污染率等性能指标进行评价。结果准确度检测结果的相对偏差<±3.0%;精密度(含批内精密度和室内精密度)检测结果变异系数<3.0%;携带污染率为0.00%;在4.4%~14.0%的检测区间内相关系数为0.9996。结论该糖化血红蛋白检测试剂产品的主要分析性能参数满足临床检测要求。Objective To evaluate the main properties of glycosylated hemoglobin detection reagents.Methods The measurement system composed with the glycosylated hemoglobin detection reagents and Automatic Glycosylated Hemoglobin Analyzer was used to evaluate the accuracy,precision,linearity,intraday precision carrying pollution rate and indoor precision of the detection reagents.Results The relative deviation of accuracy test results was≤±3.0%;The coefficient of variation of precision(including intraday precision and indoor precision)test results was≤3.0%;The carrying pollution rate was 0.00%;The correlation coefficient was 0.99961 within the detection range of 4.40%-14.00%.Conclusion The main performance parameters of the glycosylated hemoglobin testing reagents can meet all requirements in general clinical laboratory.

关 键 词：高效液相色谱法 糖化血红蛋白 精密度 携带污染率 线性范围 

分 类 号：R-331[医药卫生]