Little Randie R, Wielgosz Robert I, Josephs Ralf, Kinumi Tomoya, Takatsu Akiko, Li Hongmei, Stein Daniel, Burns Chris
Department of Pathology and Anatomical Sciences, University of Missouri School of Medicine, Columbia, MO;
Bureau International des Poids et Mesures, Sèvres Cedex, France.
Clin Chem. 2017 Sep;63(9):1447-1456. doi: 10.1373/clinchem.2016.269274. Epub 2017 Jun 23.
Assessment of endogenous insulin secretion by measuring C-peptide concentrations is widely accepted. Recent studies have shown that preservation of even small amounts of endogenous C-peptide production in patients with type 1 diabetes reduces risks for diabetic complications. Harmonization of C-peptide results will facilitate comparison of data from different research studies and later among clinical laboratory results at different sites using different assay methods.
This review provides an overview of the general process of harmonization and standardization and the challenges encountered with implementing a reference measurement system for C-peptide.
Efforts to harmonize C-peptide results are described, including those by the National Institute of Diabetes and Digestive and Kidney Diseases-led C-peptide Standardization Committee in the US, activities in Japan, efforts by the National Institute for Biological Standards and Control in the UK, as well as activities led by the Bureau International des Poids et Mesures and the National Metrology Institute in China. A traceability scheme is proposed along with the next steps for implementation. Suggestions are made for better collaboration to optimize the harmonization process for other measurands.
通过测量C肽浓度来评估内源性胰岛素分泌已被广泛接受。最近的研究表明，1型糖尿病患者即使保留少量内源性C肽分泌也能降低糖尿病并发症的风险。C肽检测结果的标准化将有助于比较不同研究的数据，以及日后使用不同检测方法的不同实验室的临床检测结果。
本综述概述了标准化的一般过程以及实施C肽参考测量系统所面临的挑战。
文中描述了统一C肽检测结果的各项努力，包括美国国立糖尿病、消化和肾脏疾病研究所牵头的C肽标准化委员会所做的工作、日本开展的活动、英国国家生物标准与控制研究所所做的努力，以及国际计量局和中国国家计量院牵头开展的活动。文中提出了一个可追溯性方案以及下一步的实施计划。对于加强合作以优化其他被测量物的标准化过程，文中也给出了建议。
