MQ-2000PT糖化血红蛋白分析仪性能验证  

Performance verification of MQ-2000PT glycosylated hemoglobin analyzer

作　　者：朱延清[1] 吴文新[1] 吴文君[1] 朱舜琦 Zhu Yanqing;Wu Wenxin;Wu Wenjun;Zhu Shunqi(Department of Clinical Laboratory,the People's Hospital of Dianshan Lake,Kunshan City,Jiangsu Province 215345)

机构地区：[1]江苏省昆山市淀山湖人民医院检验科,215345

出　　处：《中国社区医师》2017年第24期108-109,113,共3页Chinese Community Doctors

摘　　要：目的:对MQ-2000PT全自动糖化血红蛋白分析仪进行性能验证。方法:按照CLIS EP15-A2文件进行准确度、精密度评价;按照WS/T 408-2012和402-2012文件进行线性范围和参考区间验证。结果:批内、批间精密度均<3%;20例健康成人Hb A1c检测值,结果在参考范围内19例,引用厂家的参考区间,在4.0%~6.0%为有效;溯源样本1靶值5.3%,样本2靶值8.7%,测得的偏离度均<3%,准确度验证通过。结论:MQ-2000PT糖化血红蛋白分析仪具有重复性好、检测结果准确、分析速度快等特点,可定量检测患者血液中糖化血红蛋白的含量。Objective:The performance of MQ-2000PT automatic hemoglobin analyzer was verified.Methods:We evaluted theaccuracy and precision according to the CLIS EP15-A2document.We validated the linear range and the reference intervalaccording to the WS/T408-2012and402-2012files.Results:The intra-and inter-batch precision was less than3%.HbA1c valuesof20healthy adults were measured and19cases within the reference range,the reference to the manufacturer's reference rangefrom4.0%to6.0%effective.The target value of traceability sample1was5.3%,and sample2was8.7%,and the deviation was lessthan3%,the accuracy was verified by.Conclusion:MQ-2000PT glycosylated hemoglobin analyzer has the characteristics of goodrepeatability,accurate detection and rapid analysis.It can quantitatively detect the content of glycosylated hemoglobin in the bloodof patients.

关 键 词：糖化血红蛋白 高效液相色谱法 性能验证 

分 类 号：R446.1[医药卫生—诊断学]