【摘要】 目的 比较两种HbA1c床旁检测方法的性能。 方法 通过对已发表的对两种HbA1c床旁检测方法(POC A，POC B)与两种中心实验室仪器(Central X，Central Y )验证试验的数据分析得到两种HbA1c床旁检测仪器与中心实验室仪器相比的不精密度(CV%)、偏倚(Bias%)，并将其与质量要求进行比较。 结果 POC A测定HbA1c在6.0%和10.4%浓度水平时的变异系数(CV)分别为3.8%、3.7%，与中心实验室仪器(Central X)比对测得的偏倚分别为10.33%、13.58%，与中心实验室仪器(Central Y)比对得到的偏倚分别为7.83%、10.44%; POC B测定HbA1c在5.5%和11.9%浓度水平时的CV分别为3.4%、7.3%，与Central X比对测得的偏倚分别为0.45%、11.08%，与Central Y比对得到的偏倚分别为3.73%、9.57%。 结论 两种HbA1c床旁检测方法的性能不能满足目前对HbA1c检测的质量要求。

　　【关键字】 性能评价;床旁检测;糖化血红蛋白

　　Comparison of the two Point-of-care testing methods for glycated haemoglobin testing WANG Wei, YANG Xue, Hu Li-tao, et al. National Center for Clinical Laboratories, Beijing Hospital, Beijing 100730, China

　　Corresponding author: WANG Zhi-guo, E-mail:zgwang@nccl.org.cn

　　【Abstract】 Objective To evaluate the performance of two Point-of-care testing (POCT) methods for HbA1c testing. Methods Using the published data from a study comparing two POCT HbA1c devices with the two central laboratory instruments for HbA1c measurement, the imprecision (CV%) and bias (Bias%) for the two methods POC A and POC B were determined by verification tests with two central laboratory instruments Central X and Central Y, from the published data, and then compared with the requirement of quality. Results The total CV of POC A was 3.8% and 3.7% respectively at the concentration level 6.0% and 10.4%, and when comparing with the central laboratory instrument Central X, the bias of POC A was 10.33% and 13.58%. Comparing with Central Y, the bias was 7.83% and 10.44%. The total CV of POC B was 3.4% and 7.3% at the concentration level 5.5% and 11.9% respectively, and when comparing with Central X, the bias was 0.45% and 11.08%. Comparing with Central Y, the bias was 3.73% and 9.57%. Conclusion The performance of the two methods for HbA1c testing cannot meet the current quality requirements for the HbA1c testing.

　　【Key words】 Performance evaluation; Point-of-care testing (POCT); HbA1c