Standardization of C-Peptide and HbA1c Measurements Program

C 肽和 HbA1c 测量程序标准化

• 批准号: 9389632
• 负责人: Randie Little
• 金额: $ 174.38万
• 依托单位: UNIVERSITY OF MISSOURI-COLUMBIA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-01 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9389632
• 关键词: Affect; American; Beta Cell; Biological; Biological Assay; Biological Preservation; Blood Glucose; Blood Vessels; Blood specimen; C-Peptide; Calibration; Capillary Electrophoresis; Caring; Cell physiology; Certification; Chronic; Chronic Disease; Clinical; Clinical Chemistry; Clinical Research; Complications of Diabetes Mellitus; Data; Data Analyses; Data Reporting; Development; Diabetes Mellitus; Diagnosis; Diagnostic; Disease; Disease Progression; Effectiveness; Evaluation; Eye; Fostering; Freezing; Glycosylated hemoglobin A; Goals; Heart; Hemoglobin; Hyperglycemia; Insulin; Insulin-Dependent Diabetes Mellitus; International; Kidney; Laboratories; Manufacturer Name; Measurement; Methods; Monitor; Pathologist; Performance; Peripheral Nerves; Publishing; Research; Research Project Grants; Risk; Scheme; Site; Specific qualifier value; Specificity; Standardization; Testing; Therapeutic Intervention; United States National Institutes of Health; Update; Variant; Whole Blood; base; clinical diagnostics; college; diabetes control; glycemic control; high risk; improved; meetings; member; polypeptide C; programs; tool; web site

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.

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 在美国，大约有3000万人监测血糖控制， 传统上被认为是糖尿病护理的基石。的重要性 通过研究证明了直接关系， 平均血糖与慢性胰腺炎的发生和进展之间的关系 糖尿病并发症具有里程碑意义的糖尿病控制和并发症试验 （DCCT），1993年完成，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水平密切相关， 对照，通过HbA 1c测定进行评估。HbA 1c作为标志物的重要性 糖尿病的血糖控制，最近作为一种诊断工具， 很好地建立了。该拟议项目将改善HbA 1c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， 认证，监测实验室方法和实验室的性能，以及 检测和发布HbA 1c分析和生物干扰数据。 在1型糖尿病中，保护β细胞功能已被确定为重要的 目的是在发病时延缓疾病进展， 干预C肽的准确、标准化测量将有助于实现这一目标， 这也是本提案的主题。标准化将通过以下方式实现： 通过重新校准C肽方法实施溯源性方案， 每个制造商，并通过评估 能力验证数据。此外，还将制定可接受的准确度标准， C肽测定的精密度和特异性。

项目成果

Investigation of 2 models to set and evaluate quality targets for hb a1c: biological variation and sigma-metrics.

• DOI: 10.1373/clinchem.2014.235333
• 发表时间: 2015-05
• 期刊: Clinical chemistry
• 影响因子: 9.3
• 作者: Weykamp C;John G;Gillery P;English E;Ji L;Lenters-Westra E;Little RR;Roglic G;Sacks DB;Takei I;IFCC Task Force on Implementation of HbA1c Standardization
• 通讯作者: IFCC Task Force on Implementation of HbA1c Standardization

Use of cation exchange chromatography for human C-peptide isotope dilution - mass spectrometric assay.

• DOI: 10.1016/j.chroma.2011.10.080
• 发表时间: 2011-12-23
• 期刊: Journal of chromatography. A
• 作者: Stoyanov AV;Rohlfing CL;Connolly S;Roberts ML;Nauser CL;Little RR
• 通讯作者: Little RR

Measurement of Hba(1C) in patients with chronic renal failure.

• DOI: 10.1016/j.cca.2012.12.022
• 发表时间: 2013-03-15
• 期刊: Clinica chimica acta; international journal of clinical chemistry
• 作者: Little RR;Rohlfing CL;Tennill AL;Hanson SE;Connolly S;Higgins T;Wiedmeyer CE;Weykamp CW;Krause R;Roberts W
• 通讯作者: Roberts W

Assessing quality from an accuracy-based HbA1c proficiency survey.

通过基于准确性的 HbA1c 熟练程度调查评估质量。

• DOI: 10.1515/cclm-2015-0972
• 发表时间: 2016
• 期刊: Clinical chemistry and laboratory medicine
• 影响因子: 6.8
• 作者: Little,RandieR;Rohlfing,CurtL
• 通讯作者: Rohlfing,CurtL

The long and winding road to optimal HbA1c measurement.

• DOI: 10.1016/j.cca.2012.12.026
• 发表时间: 2013-03-15
• 期刊: Clinica chimica acta; international journal of clinical chemistry
• 作者: Little RR;Rohlfing CL
• 通讯作者: Rohlfing CL