糖化血红蛋白（HbA1c）的应用现状

HbA1c
An Overview of Current Analytical Testing Issues

By Randie R. Little, PhD and Curt L. Rohlfing

The global prevalence of diabetes mellitus continues to increase rapidly, with more than 280 million people diagnosed worldwide. By 2030, experts predict that the number of people with diabetes will soar to 439 million. Measuring glycated hemoglobin (GHB) has long been fundamental to managing patients with diabetes. Reported by clinical laboratories as HbA1c, this marker is not only used to monitor long-term glycemic control, but also to adjust therapy, assess quality of care, and predict risk for the development of complications.

The results of the landmark Diabetes Control and Complications Trial (DCCT) and its continuation as the Epidemiology of Diabetes Interventions and Complications (EDIC) Trial, as well as the United Kingdom Prospective Diabetes Study (UKPDS) (1–3), collectively underscored the importance of HbA1c as a disease management tool. These two prospective long-term randomized trials conclusively demonstrated that intensive glycemic control significantly reduces the risk of long-term diabetes complications and allowed diabetologists to establish specific treatment goals based on HbA1c.For example, the American Diabetes Association (ADA) recommends that HbA1c levels be routinely obtained in all patients with diabetes at least two to four times per year（糖尿病人每年2-4次的HbA1c常规检测，可见市场容量非常庞大！！） and that non-pregnant adults should aim for HbA1c levels <7% (4).Other clinical organizations, worldwide, have also set treatment goals for HbA1c. More recently, ADA recommended using HbA1c levels to diagnose diabetes. These new recommendations set HbA1c levels >6.5% for diagnosis and levels 5.7–6.4% as an indication of increased risk for diabetes (4).

With this heightened attention on HbA1c for optimal diabetes treatment and diagnosis, it is imperative that clinical labs have accurate and reliable methods to measure the marker.This article will describe the current state of and efforts to improve HbA1c testing and discuss analytical issues laboratories need to consider for optimal assay performance（这篇文章主要描述现阶段HbA1c这个指标的检测现在及为改进这个指标所做的努力；并讨论了临床实验室在使用这个指标时应该考虑的注意事项）.