摘要目的 分析全国糖化血红蛋白正确度验证数据,了解我国临床实验室检测方法的质量状况.方法 方法偏倚评估研究.收集北京医院临床实验室检验HbA1c剩余样本,制备两个浓度水平(批号为201311和201312)的冰冻混合人血液样本,通过干冰运输至参加实验室.实验室在间隔一周的三个工作日对样本进行15次重复检测,通过网络回报结果;同时采用IFCC参考方法对样本进行检测确定指定值.统计参加实验室的分析系统类型、所有实验室内及实验室间稳健变异系数、分组后实验室间稳健变异系数及偏倚等.偏倚评价标准为±4.5％.结果 106家实验室回报了检测结果,其中高效液相色谱法88家、免疫比浊法13家、酶法5家;201311样本实验室内变异系数范围0％～4.6％,中位数为1.1％;201312样本检测实验室内变异系数范围为0％ ～4.5％,中位数为0.9％;201311和201312单次检测实验室间稳健变异系数5.6％和6.1％,两个批号各15次检测均值的实验室间稳健变异系数分别为5.9％及5.6％.两个批号样本Bio-Rad、Tosoh、Arkray、Primus仪器组的实验室间稳健变异均小于5％.201311和201312两个批号样本偏倚通过率为61/106(57.5％)和56/106(52.8％).各组两个批号样本的通过率分别为:Bio-Rad组均为19/45(42.2％),Tosoh组为85％(17/20)、75％ (15/20),Arkray组为71％ (10/14)、50％(7/14),Primus组为6/8、5/8,免疫比浊法均为46.2％(6/13),酶法组均为3/5.结论 大部分实验室HbA1c检测的正确度水平符合标准,部分实验室还需改进,室间质评组织机构、生产厂家和临床实验室需共同努力来实现我国HbA1c检测的标准化.

abstractsObjective To assess system deviation of HbA1c measurement in clinical laboratories in China by the national trueness verification project.Methods Bias assessing research.Two lots samples of human whole blood pools with different HbA1c concentration levels were prepared and sent to laboratories by dry ice package.Laboratories were asked to measure these samples in 5 repeats per set in three consecutive Wednesday separately,results were reported through Web-based software.Meanwhile the IFCC reference measurement procedure was applied to assign HbA1c reference values for the two lots samples.The following information or data were analyzed:measurement systems,intra-lab CVs and inter-lab robust CVs of all laboratories,inter-lab robust CVs and bias based on peer groups,et.al.The criterion of bias was set at ± 4.5％.Results 106 of 120 laboratories submitted results,including 88 using high performance liquid chromatography method,13 using immune turbidimetry method and 5 using enzymatic methods the intra-lab CVs of lot 201311 ranged from 0 to 4.6％,with median of 1.1％,while for lot 201312 the intra-lab precision ranged from CV0 to CV4.5％,with median of CV0.9％.The inter-lab robust CVs of 201311 and 201312 with single determinations were 5.6％ and 6.1％ and inter-lab robust CVs of 201311 and 201312 of each lab's average results were 5.9％ and 5.6％ respectively.The inter-lab CVs of group BIO-RAD,TOSOH,ARKRAY and PRIMUS at two level were less than 5％.For all laboratories,the percents of pass of 201311 and 201312 were 61/106(57.5％) and 56/106(52.8％) respectively.The pass ratio of each group on two lots were as follows:of group BIO-RAD were both 19/45 (42.2％),of group TOSOH were 85％ (17/20) and 75％ (15/20),of group ARKRAY were 71.4％ (10/14) and 50％ (7/14),of group PRIMUS were 6/8,5/8; of group immune turbidimetric method were both 46.2％ (6/13) and of group enzymatic were both 3/5.Conclusions There were improvement for the performance of trueness of HbA1c measurement in domestic laboratories,while some of them should be addressed.Academic,research institutions,EQA organizer,manufacturers and clinical laboratories should work together to achieve the standardization of HbA1c measurement.