基金项目：国家高技术研究发展计划资助项目(2011AA02A116)

　　作者单位：100730北京，卫生部北京医院卫生部临床检验中心

　　通讯作者：陈文祥，E-mail：wxchen@nccl.org.cn

　　张传宝 闫颖 赵海舰 张江涛 马嵘 张天娇 王冬环 曾洁 陈文祥

　　【摘要】 目的 验证4个HbA1c测定系统的正确度、精密度，以判断是否符合相关要求，为临床实验室的使用提供相关依据。 方法 采用一种简便的实验方案，在5 d内，对3个基于离子交换高效液相色谱法和1个基于免疫比浊法原理的HbA1c测定系统进行精密度和正确度验证实验，计算各个系统的批内精密度、实验室内精密度及测定结果的正确度。 结果 4个系统的批内精密度CV为0.26%～1.02%，实验室内精密度CV为0.28%～1.50%;4个系统测定标准物质的均值[美国国家HbA1c标准化计划(NGSP)值]和标准物质定值的偏倚为-0.34% HbA1c～0.41%HbA1c，与国际临床化学与检验医学联合会(IFCC)定值导出的NGSP值的偏倚为-0.14% HbA1c～0.60%HbA1c。 结论 4个系统的批内精密度和实验室内精密度及正确度性能符合相关要求，能满足临床工作的需要。

　　【关键词】糖尿病;糖化血红蛋白;免疫比浊法;离子交换高效液相色谱法

　　doi:10.3969/j.issn.1006-6187.2011.11.002

　　注：主要分析系统和设备

　　1.日本东曹(TOSOH)HLC-723 G7 HbA1c测定仪及其配套试剂及校准品(简称G7)，离子交换高效液相色谱法。

　　2.日本爱科来(Arkray)ADAMSTMA1c HA-8160 HbA1c测定仪及其配套试剂及校准品(简称8160)，离子交换高效液相色谱法。

　　3.美国伯乐(Bio-Rad)D-10 HbA1c测定仪及其配套试剂和校准品(简称D10)，离子交换高效液相色谱法。

　　4.日立7170A自动生化分析仪/罗氏(Roche)免疫比浊法HbA1c试剂盒及校准品(简称Roche)。

　　Verification of performance for precision and trueness of four HbA1c measurement systems

　　ZHANG Chuan-bao, YAN Ying, ZHAO Hai-jian, et al. Beijing Hospital, National Center for Clinical Laboratories, Beijing 100730, China

　　Corresponding author: CHEN Wen-xiang，E-mail: wxchen@nccl.org.cn

　　【Abstract】 Objective To verify the performance for precision and trueness of 4 glycated hemoglobin measurement systems, to determine whether relevant requirements are fulfilled, and to provide guidelines for clinical laboratory staff and clinicians. Methods A simple experiment protocol was applied to verify in five days the performance for precision and trueness of 4 HbA1c measurement systems, three of which were based on ion-exchange high-performance liquid chromatography and one based on immune turbidimetric assay, Within-run and within-lab precisions and trueness were calculated and evaluated against requirements. Results The within-run precision and within-laboratory CVs of four systems were 0.26%~1.02% and 0.28%~1.5% respectively. The bias of four systems were -0.34% HbA1c ~ 0.41% HbA1c (NGSP value) and -0.14% HbA1c ~ 0.61% HbA1c(value derived from the IFCC- NGSP equation). Conclusions The performance of within-run and intra-lab precision and trueness of 4 systems meets relevant requirements and clinical needs.

　　【Key words】 Diabetes;Glycated hemoglobin;Immune turbidimetric assay;Ion-exchange high-performance liquid chromatography