ARKRAYHA-8180全自动糖化血红蛋白分析仪性能评价

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（HbAlc）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HbAlc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 HbAlc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HbAlc性能良好,可在临床广泛使用.

Performance Evaluation of the ARKRAY HA-8180 Automatic Glycosylated Hemoglobin Analyzer for HbAlc

Objective To evaluate the performance of ARKRAY HA-8180 automatic glycosylated hemoglobin analyzer（ HA-8180 ） for the determination of glycosylated hemoglobin Alc（HbAlc） 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 HbAlc 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 HbAlc 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 HbAlc determination, and can be widely used in clinical application .