目的 对以离子交换高效液相色谱（HPLC）法为原理的ARKRAY HA-8180型全自动糖化血红蛋白分析仪（简称HA-8180）检测全血糖化血红蛋白(HbA1c) 的性能进行评价。方法 参考美国临床和实验室标准化协会（CLSI）文件（EP15-A2, EP6-A, EP28-A3C）及相关文献，对HA-8180测定HbA1c的精密度、携带污染、准确度、回收试验、线性范围以及生物参考区间等进行评价，并将实验结果与制造商提供的分析性能或公认的质量指标进行比较。结果 HbA1c低值和高值样本对应的重复性不精密度变异系数（CV）分别为0.76%和0.50%，实验室内不精密度CV分别为0.79%和0.51%；高值样本对低值样本的结果无明显携带污染（携带污染率为1.08%）；相对偏倚在-1.39%~1.29%之间，偏差符合率为100%；平均回收率为101.54%；在4.7%~15.8%范围内线性良好；生物参考区间验证结果在美国糖尿病控制与并发症试验／英国前瞻性糖尿病研究（DCCT／UKPDS）提供的4.0%～6.0%范围内。结论 HA-8180糖化血红蛋白分析仪检测全血HbA1c性能良好，可在临床广泛使用。

Objective To evaluate the performance of ARKRAY HA-8180 automatic glycosylated hemoglobin analyzer (HA-8180) for the determination of glycosylated hemoglobin A1c (HbA1c) in whole blood with the principle of ion-exchange high performance liquid chromatography (HPLC). Methods The precision, carryover, accuracy, recovery test, linearity and reference interval of HbA1c were determined by HA-8180 based on the Clinical and Laboratory Standards Institute (CLSI) evaluation protocols EP15-A2, EP6-A, EP28-A3C. The results were compared with the performance analysis of the manufacturer or recognized quality index. Results The repeatability and within-laboratory precision coefficients of variation (CV) of both low and high levels of HbA1c were 0.76%, 0.50% and 0.79%, 0.51%, respectively. There was no obvious carryover when high level and low level samples were analyzed sequentially, and the carryover rate was 1.08%．The relative bias was between -1.39 to 1.29%, and the bias coincidence was 100%．The average recovery rate was 101.54%. The results showed a good linearity in a range of 4.7 - 15.8%. The biotic reference intervals were in the range of 4.0 - 6.0%, provided by Diabetes Control and Complication Trail/United Kingdom Prospective Diabetes Study (DCCT／UKPDS)．Conclusion HA-8180 has a good performance for HbA1c determination, and can be widely used in clinical application