关键词: 糖化血红蛋白, 参考方法, 总误差, 生物医学变异

Abstract:

Objective To improve the traceability of glycated hemoglobin A_1c（HbA_1c） in Shanghai Center for Clinical Laboratory with establishing the International Federation of Clinical Chemistry and Laboratory Medicine （IFCC） Secondary Reference Measurement Procedure,through tracing from the IFCC Primary Reference System. Methods Using 4 HbA_1c determination systems,including HA-8180,Hb-9210,Capillarys 2 Flex Piercing （Cap2） and MQ2000-PT with their original reagents and calibrators,the results of 24 samples sent by IFCC were compared with the target values assigned by the IFCC Primary Reference System. The performance of the 4 determination systems were evaluated by the IFCC rules. Results The coefficients of variation （CV） of the 4 determination systems were 1.1% for HA-8180,2.0% for Hb-9210,2.2% for Cap2 and 2.0% for MQ2000-PT. The imprecisions were 0.6,1.0,1.1 and 1.0 mmol/mol,respectively. The |biases| at the level of 50 mmol/mol were 1.0,1.1,0.4 and 1.0 mmol/mol,respectively. The total errors （TE） of whole year were 2.2,3.1,2.6 and 3.2 mmol/mol,respectively. According to the rules,HA-8180 got a "Sliver" score,and Hb-9210,Cap2 and MQ2000-PT got "Bronze" score. Conclusions The 4 determination systems demonstrate traceability to the IFCC Secondary Reference Measurement Procedure.

Key words: Glycated hemoglobin A_1c, Reference measurement procedure, Total error, Biological variation