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。这种疾病非常普遍， 影响美国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。它的重要性 已经通过研究证明了一种直接的 平均血糖与糖尿病发生发展的关系 糖尿病的慢性并发症。里程碑式的糖尿病控制和 1993年完成的并发症试验(DCCT)表明，发展的风险 和/或1型糖尿病慢性并发症的进展密切相关 与糖化血红蛋白测定评估的血糖控制程度有关。 糖化血红蛋白作为糖尿病患者血糖控制指标的重要性 最近，作为一种诊断工具，现在已经很成熟了。这项拟议的项目 将改进HbA1c的测量，以实现最佳的临床和诊断用途。 这将通过一个既定的标准化计划来完成，通过不断地 严格方法和实验室认证标准，监控性能 实验室方法和实验室，以及测试和发布HbA1c数据 分析和生物干扰。 1型糖尿病患者β细胞功能的保存被认为是一种 重要的目标是在发病时延缓疾病的进展，并对 治疗性干预。C-肽的准确、标准化测量将 帮助实现这一目标，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- 每个制造商的多肽方法，并监测重新校准的效果 通过对能力测试数据的评估。此外，还将为以下方面制定标准 C肽分析的准确度、精密度和特异度均可接受。

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.