TOSOH HLC-723 G8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法（HPLC）为原理的TOSOHHLC-723G8全自动糖化血红蛋白分析仪（简称HLC-723G8）检测全血糖化血红蛋白（HbA1c）的性能进行评价。方法对HLC-723G8测定HbA1c的精密度、相关性、线性、携带污染进行评价，并检测54例健康体检者的HbA1c进行参考区间验证。结果HLC-723G8测定HbA1c低、高水平批内变异系数（cv）分别为0．00％、0．47％，批间CV分别为0．76％、0．31％；HLC-723G8与HLC-723G7全自动糖化血红蛋白分析仪测定HbA1c的结果呈明显相关（F2=0．999，P〈0．001），预期偏倚为0．06，相对偏倚值为0．83％，偏差符合率为100％；在5％～12％范围内线性良好（r2=0．9996，P〈0．001）；高值标本对低值标本的结果无明显携带污染（携带污染率为1．12％）；54名健康人群的HbA1c测定结果为4．7％-6．3％，在厂家提供的参考区间内。结论HLC-723G8测定HbA1c的性能良好，可在临床使用。

Performance evaluation of TOSOH HLC-723 G8 automatic glycohemoglobin analyzer

Objective To evaluate the performance of TOSOH HLC-723 G8 automatic glycohemoglobin analyzer （HLC-723 G8） for the determination of glycosylated hemoglobin A1c （HbA1c） 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 HbAlc was verified among 54 healthy subjects. Results The within-run and between-run coefficients of variation （CV） of both low and high levels of HbA1c were 0.00% ,0.47% and 0.76% , 0.31%, respectively. HLC-723 G8 and HLC-723 G7 for the determination of HbAjc 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 HbA1c 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 HbA1c 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.