本文系统解读了我国学者2023年发表的关于血清C肽检测标准化的两项关键研究。这两项研究针对国内C肽检测结果存在显著差异的问题，构建了完整的标准化技术体系。首先，针对国内C肽检测结果存在显著差异的问题，研究建立了同位素稀释液相色谱－串联质谱（ID-LC-MS/MS）参考方法，该方法精密度（≤2.2%）和正确度（回收率99.6%~101.0%）优异，可实现SI单位溯源。方法学比较显示常规免疫分析法存在明显偏差（32.2%~81.7%），但经参考方法定值的冷冻人血清池校准后显著改善（偏差降至-6.0%~1.2%）。研究同时筛选出具有良好互换性和稳定性的冷冻人血清池作为候选参考物质，为解决室间质量评价中物质互换性问题提供了方案。这两项研究构建了“参考方法－参考物质－标准化应用”的完整体系，为提升我国C肽检测结果一致性提供了重要技术支撑，对推进糖尿病精准诊疗具有重要意义。

This article provides a systematic interpretation of two pivotal studies on the standardization of serum C-peptide measurement published in China in 2023. Addressing the significant variability in C-peptide test results across domestic laboratories, the research established an isotope-dilution liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) reference method. This method demonstrated excellent performance, with precision ≤2.2% and accuracy (recovery rate) of 99.6%~101.0%, enabling traceability to SI units. Method comparison revealed substantial biases (32.2%~81.7%) in routine immunoassays, which were significantly reduced (to -6.0%~1.2%) after recalibration using frozen human serum pools (FHSP) assigned by the reference method. Furthermore, the studies identified FHSPs as candidate reference materials with satisfactory commutability and stability, offering a solution for the commutability issues prevalent in external quality assessment (EQA) programs. Together, these two studies construct a complete "reference method - reference material - standardization application" system, providing crucial technical support for improving the consistency of C-peptide measurement in China and holding significant importance for advancing precise diagnosis and treatment of diabetes.