两款糖化血红蛋白床旁分析仪的正确性评价  

An Estimation of Two Point-of-care Testing (POCT) Hemoglobin Alc (HbA1c) Instruments

作　　者：王尉 郑华荣[2] 周睿[3] 宋智心[4] WANG Wei;ZHENG Hua-rong;ZHOU Rui;SONG Zhi-xin(Department of Blood Transfusion,Beijing Ditan Hospital,Capital Medical University,Beijing 100015,China;National Institute of Metrology,Beijing 100013,China;Department of Clinical Laboratory,Beijing Chaoyang Hospital Affiliated to Capital Medical University,Beijing 100020,China;Department of Clinical Laboratory,Fang-shan Liangxiang Hospital,Beijing 102401,China)

机构地区：[1]首都医科大学附属北京地坛医院输血科,北京100015 [2]中国计量科学研究院,北京100013 [3]首都医科大学附属北京朝阳医院检验科,北京100020 [4]北京市房山区良乡医院检验科,北京102401

出　　处：《标记免疫分析与临床》2019年第5期871-873,共3页Labeled Immunoassays and Clinical Medicine

基　　金：首都卫生发展科研专项项目(编号:2016-1-2031);国家临床重点专科建设项目

摘　　要：目的借助二级参考测量程序(SRMP),探讨两款床旁(point-of-care testing,POCT)糖化血红蛋白(HbA1c)分析仪的正确性。方法依据美国临床和实验室标准化协会(CLSI)Ep9-A2选取40份临床EDTA抗凝静脉全血样本,用比对的方式,分别评价两款POCT HbA1c分析仪与SRMP间的偏倚。结果POCT-1和POCT-2相关方程分别为,Y=1.0424X-0.3144和Y=1.0054X-0.2242相关系数(r)分别为0.9959和0.9469。临床各诊断切点处,偏倚小于美国国家糖化血红蛋白标准化计划(NGSP)和美国病理家协会(CAP)的要求(±6%)。结论两款POCTHbA1c分析仪与溯源到IFCC参考方法的SRMP比对具有良好的正确性,可以满足临床使用。Objective By using the secondary reference measurement procedure(SRMP),we were to estimate the performances of 2 point-of-care testing(POCT)hemoglobin A1c(HbA1c)instruments.Methods We estimated the bias of two POCT HbA1c instrument respectively,which were compared with the SRMP using 40 EDTA-anticoagulated venous whole-blood following the guidelines described by the Clinical an Laboratory Standards Institute(CLSI)EP9-A2 protocol.Results The regression equations of POCT-1 and POCT-2 were Y =1.0424 X -0.3144 and Y =1.0054 X -0.2242,and the correlation coefficient( r )were 0.9918 and 0.9469,respectivaly.The bias of the key cut-off points for clinical diabetes diagnosis was less than the National Glycohemoglobin Standardization Program(NGSP)and College of American Pathologists(CAP)standards(±6%).Conclusion The 2 POCT HbA1c instruments are comparable with SRMP based on IFCC reference method,and could meet the standard of the clinical usage.

关 键 词：床旁检测 糖化血红蛋白 糖尿病 

分 类 号：R446.1[医药卫生—诊断学]