·HbA1c测定和应用·

　　【摘要】 目的 提出一套评估HbA1c床旁检测(POC)仪器性能验证的程序。 方法 针对一篇已发表的评估HbA1c POC仪器性能的研究，依据临床和实验室标准化研究院(CLSI)EP-5文件获得不精密度，CLSI EP-9文件获得比对数据，运用误差网格图对比，对结果进行分析。 结果 HbA1c不精密度分析显示，两个不同浓度水平(约5%和11%)的CV%范围为1.4%(HbA1c浓度6.3%)至5.3%(HbA1c浓度6.1%)，8台仪器中仅2台满足CV%为3.0%要求，建议浓度范围在医学决定水平上，HbA1c两个浓度水平最好为6.5%和9.0%。方法比对中，按照美国糖化血红蛋白标准化组织(NGSP)0.85%的标准，仅2台仪器能满足性能要求。 结论 HbA1c POC仪器为患者血糖的监测带来了便利，但其性能暂不理想。

　　【关键词】 HbA1c;床旁检测;性能验证

　　Analysis on the performance of 8 HbA1c point-of-care instruments YANG Xue, Wei Wang , WANG Zhi-guo. National Center for Clinical Laboratories(NCCL)，Beijing Hospital of the Ministry of Health, Beijing 100730，China

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

　　【Abstract】 Objective To provide a process for assessing the performance of hemoglobin A1c point-of-care instruments. Methods Imprecision and comparison data for the 8 HbA1c POC instruments were determined according the documents EP-5 and EP-9 of clinical and laboratory standardization institute(CLSI)respectively from the published data. Error grid for the HbA1c was used to assess the accuracy for each method. Results The two different concentrations of samples, 5% and 11%, the CV% from 1.4% at the level 6.3% to 5.3% at the level 6.1%, were used to assess the imprecision. The concentrations, 6.5% and 9.0%, were suggested to assess the imprecision. Only two of the POC instruments could meet the quality requirements for the HbA1c testing, based on the NGSP criterion. Conclusion The HbA1c point-of-care instruments bring great convenience to the patients for monitoring their blood glucose, but the performance of these instruments is not yet meeting the quality requirements at present.

　　【Key words】Hemoglobin A1c; Point-of-care; Performance verificatio