关键词: 高效液相色谱法, 糖化血红蛋白, 性能评价

Abstract:

Objective　To evaluate the performance of TOSOH HLC-723 G8 automatic glycohemoglobin analyzer (HLC-723 G8) for the determination of glycosylated hemoglobin A_1c (HbA_1c) with the principle of ion-exchange high-performance liquid chromatography (HPLC). Methods　The precision,correlation,linearity and carryover of HLC-723 G8 were evaluated. The reference interval of HbA_1c was verified among 54 healthy subjects. Results　The within-run and between-run coefficients of variation (CV) of both low and high levels of HbA_1c were 0.00%,0.47% and 0.76%, 0.31%, respectively. HLC-723 G8 and HLC-723 G7 for the determination of HbA_1c showed good correlation (r²=0.999,P<0.001). The expected bias was 0.06,the relative bias was 0.83%,and the bias coincidence was 100%. An excellent linearity was found for HbA_1c in the range of 5%-12% (r²=0.999 6,P<0.001).There was no obvious carryover in both low and high level samples, and the carryover rate was 1.12%. The levels of HbA_1c among the 54 healthy subjects were 4.7%-6.3% in the range provided by manufacturers. Conclusions　HLC-723 G8 has a good performance, and can be used in clinical application.

Key words: High-performance liquid chromatography, Glycosylated hemoglobin A_1c, Performance evaluation