Abstract:

Objective To evaluate the performance of Mindray automatic H50 glycohemoglobin analyzer,and to confirm whether it meets clinical requirements. Methods According to guidelines published by the People's Republic of China health industry standard YY/T1246—2014 Glycohemoglobin Analyzer,WS/T 461—2015 Measurement of Hemoglobin A1 and the Clinical and Laboratory Standards Institute（CLSI） EP5-A2,EP6-A and EP9-A3,the carryover rate,repeatability,within-run precision,between-run precision,within-laboratory precision,linearity,comparability with BIO-RAD VariantⅡ glycohemoglobin analyzer,trueness,sample stability,interference and glycated hemoglobin E（HbE） identification were evaluated. Results The carryover rate of H50 for the determination of glycated hemoglobin A_1c（HbA_1c） was low（-0.56%）,and high-value samples were not carried to low-value samples. The results of repeatability showed that the coefficient of variation（CV） was <1%. The within-run precision,between-run precision and within-laboratory precision（CV） were <1%,which met the requirements of WS/T 461—2015. There was a wide linear range（4.2%-16.6%）,which can cover the majority of samples. The samples after storing in cold environment（4 ℃） and room temperature（18-24 ℃） were stable for 6 d. According to the requirements of the International Federation of Clinical Chemistry and Laboratory Medicine（IFCC）,the absolute bias was within ±0.3% HbA_1c. There was a positive relation with VariantⅡ（r=0.996）. The expected bias at medical decision level was <1% below the requirements of the College of American Pathologists（CAP）（6%）. Triglyceride（TG）,bilirubin and glucose（Glu） had no interference to HbA_1c. The extended model can effectively prompt for HbE. Conclusions H50 glycohemoglobin analyzer has good performance,which can meet clinical requirements.

Key words: Glycated hemoglobin A_1c, Glycohemoglobin analyzer, Performance evaluation