Data analysis of 2013 national trueness verification project of HbA1c measurement / 中华检验医学杂志

ABSTRACT

Objective 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 analyzedmeasurement 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 followsof 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.