Standardization of C-Peptide and HbA1C Measurements Program

项目摘要 糖尿病是一种以胰岛素缺乏为特征的慢性疾病， 高血糖症和眼睛，肾脏， 周围神经心脏和血管这种疾病非常普遍， 影响了美国3000多万人的血糖控制监测 传统上被认为是糖尿病护理的基石。的重要性 研究证明， 平均血糖与糖尿病发生和进展的关系 糖尿病的慢性并发症具有里程碑意义的糖尿病控制和 1993年完成的并发症试验（DCCT）表明， 1型糖尿病的慢性并发症和/或进展密切相关， 与血糖控制程度相关，通过HbA 1c测定进行评估。 HbA 1c作为糖尿病血糖控制标志物的重要性，以及 最近作为一种诊断工具，现在已经很好地建立起来。本拟议项目 将改善HbA 1c的测量，以实现最佳临床和诊断用途。 这将通过一个既定的标准化计划来完成， 收紧方法和实验室认证标准，监测绩效 实验室方法和实验室，以及HbA 1c的检测和发布数据 分析和生物干扰。 在1型糖尿病中，β细胞功能的保护已被确定为 这是延缓疾病进展的一个重要目标， 治疗干预C肽的准确、标准化测量将 这一目标的实现，也是本提案的主题。标准化将是 通过实施可追溯性计划并重新校准C- 每个制造商的肽方法，并监测重新校准的影响 通过评估能力验证数据。此外，还将制定标准， C肽测定的准确度、精密度和特异性可接受。

Project Summary 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 more than 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.