我国突破肿瘤标志物标准物质关键技术

Core Insights - The article highlights the successful development of domestic diagnostic standard materials in China, addressing the long-standing reliance on imports and the lack of unified measurement standards in critical areas such as oncology, cardiovascular, and metabolic diseases [1][2] Group 1: Development of Domestic Standards - The State Administration for Market Regulation has organized special research to overcome key technical challenges in the development of high-level standard materials, establishing a comprehensive quality evaluation and technical support system for domestic reagents [1] - The research team has achieved several core technological innovations to meet national strategic needs, including the development of serum matrix standard materials for tumor markers such as alpha-fetoprotein and prostate-specific antigen [1] Group 2: Innovations in Measurement Techniques - In the cardiovascular field, an innovative hydrogen-deuterium exchange mass spectrometry antibody assessment strategy has been developed, providing a new pathway for the standardization of cardiac troponin I (cTnI) detection [1] - A trace detection reference method for Alzheimer's disease biomarkers Aβ42/Aβ40 in serum has also been established [1] Group 3: Quality System Construction - The research has promoted the establishment of national metrology technical specifications, such as the reference method for measuring C-reactive protein in human serum, which provides authoritative technical support for the quality evaluation of domestic reagents from development to clinical application [2] - These developments have significantly improved the accuracy of test results and inter-laboratory comparability, facilitating clinical result recognition and supporting the high-quality replacement and international development of domestic diagnostic systems [2] Group 4: Industrial Application - The results of this research have been industrialized, with over 20 self-developed quality control and calibration products approved for market, effectively filling the domestic gap in related fields [2]