Department of Pathology and Anatomical Sciences, University of Missouri School of Medicine, One Hospital Dr., Columbia, MO 65212, USA.
Clin Chim Acta. 2013 Mar 15;418:63-71. doi: 10.1016/j.cca.2012.12.026. Epub 2013 Jan 11.
The importance of hemoglobin A1c (HbA1c) as an indicator of mean glycemia and risks for complications in patients with diabetes mellitus was established by the results of long-term clinical trials, most notably the Diabetes Control and Complications Trial (DCCT) and United Kingdom Prospective Diabetes Study (UKPDS), published in 1993 and 1998 respectively. However, clinical application of recommended HbA1c targets that were based on these studies was difficult due to lack of comparability of HbA1c results among assay methods and laboratories. Thus, the National Glycohemoglobin Standardization Program (NGSP) was initiated in 1996 with the goal of standardizing HbA1c results to those of the DCCT/UKPDS. HbA1c standardization efforts have been highly successful; however, a number of issues have emerged on the "long and winding road" to better HbA1c, including the development of a higher-order HbA1c reference method by the International Federation of Clinical Chemistry (IFCC), recommendations to use HbA1c to diagnose as well as monitor diabetes, and point-of-care (POC) HbA1c testing. Here, we review the past, present and future of HbA1c standardization and describe the current status of HbA1c testing, including limitations that healthcare providers need to be aware of when interpreting HbA1c results.
血红蛋白 A1c（HbA1c）作为糖尿病患者平均血糖和并发症风险的指标的重要性，是通过长期临床试验的结果确立的，尤其是糖尿病控制和并发症试验（DCCT）和英国前瞻性糖尿病研究（UKPDS），分别于 1993 年和 1998 年发表。然而，由于检测方法和实验室之间的 HbA1c 结果缺乏可比性，基于这些研究推荐的 HbA1c 目标的临床应用变得困难。因此，1996 年启动了国家糖化血红蛋白标准化计划（NGSP），目标是将 HbA1c 结果标准化为 DCCT/UKPDS 的结果。HbA1c 标准化工作取得了巨大成功；然而，在实现更好的 HbA1c 的“漫长而曲折的道路”上出现了许多问题，包括国际临床化学联合会（IFCC）开发了一种更高级别的 HbA1c 参考方法、建议使用 HbA1c 诊断和监测糖尿病，以及即时检测（POC）HbA1c 检测。在这里，我们回顾了 HbA1c 标准化的过去、现在和未来，并描述了当前 HbA1c 检测的现状，包括医疗保健提供者在解释 HbA1c 结果时需要注意的局限性。
