Standardization of C-Peptide and HbA1c Measurements Program

糖尿病是一种以胰岛素缺乏为特征的慢性疾病， 高血糖和高风险的并发症的眼睛，肾脏， 周围神经、心脏和血管。这种疾病非常流行，影响 在美国，大约有3000万人在监测血糖控制 传统上被认为是糖尿病护理的基石。重要的是 通过研究证明血糖与血糖的直接关系，已经建立了血糖监测。 平均血糖与慢性阻塞性肺疾病发生发展的关系 糖尿病的并发症。具有里程碑意义的糖尿病控制和并发症试验 1993年完成的(DCCT)表明，发展和/或进展的风险 1型糖尿病的慢性并发症与血糖升高程度密切相关 对照，通过HbA1c测定进行评估。糖化血红蛋白作为标志物的重要性 糖尿病的血糖控制，以及最近作为一种诊断工具，现在 久负盛名。这项拟议的项目将改善以下方面的HbA1c的测量 最佳的临床和诊断用途。这将通过一个既定的 通过不断收紧方法和实验室标准的标准化计划 认证，监测实验室方法和实验室的性能，以及 测试和发布HbA1c分析和生物干扰的数据。 1型糖尿病患者胰岛β细胞功能的保存已被认为是一项重要的 目的是在发病时延缓疾病的进展，也是为了治疗 干预。准确、标准化的C肽测量将有助于实现这一目标，并 也是这项提案的主题。标准化将通过以下方式实现 通过以下方式实施C-肽方法重新校准的可追溯性方案 通过评估每个制造商并监控重新校准的效果 能力测试数据。此外，将为可接受的准确度制定标准， C-肽检测的精密度和特异性。

Diabetes mellitus is a chronic disorder characterized by insulin deficiency, hyperglycemia and high risk for development of complications of the eyes, kidneys, peripheral nerves, heart and blood vessels. The disease is highly prevalent, affecting approximately 30 million people in the U.S. Monitoring of glycemic control has traditionally been considered a cornerstone of diabetes care. The importance of monitoring glycemia has been established by studies proving a direct relationship between mean blood glucose and the development and progression of the chronic complications of diabetes. The landmark Diabetes Control and Complications Trial (DCCT), completed in 1993, showed that risks for development and/or progression of the chronic complications of type 1 diabetes is closely related to the degree of glycemic control, as assessed by HbA1c determinations. The importance of HbA1c as a marker of glycemic control in diabetes mellitus, and more recently as a diagnostic tool, is now well established. This proposed project will improve the measurement of HbA1c for optimal clinical and diagnostic use. This will be done through an established standardization program by continuously tightening criteria for method and laboratory certification, monitoring performance of laboratory methods and laboratories, and testing and publishing data on HbA1c analytical and biological interferences. Preservation of beta cell function in type 1 diabetes has been identified as an important goal in delaying progression of the disease at onset and also for therapeutic intervention. Accurate, standardized measurement of C-peptide will aid in this goal and is also the subject of this proposal. Standardization will be accomplished by implementation of a traceability scheme with re-calibration of C-peptide methods by each manufacturer and monitoring the effects of re-calibration by evaluation of proficiency testing data. In addition, criteria will be formulated for acceptable accuracy, precision and specificity of C-peptide assays.