Standardization Challenges and Breakthroughs in Apolipoprotein B Detection: From Immunoassays to LC‐MS/MS

Apolipoprotein B (apoB) is a key biomarker for risk assessment and treatment monitoring of atherosclerotic cardiovascular disease (ASCVD). Its clinical value has been validated by multiple studies, and its predictive performance for ASCVD risk is significantly superior to conventional lipid indicators in populations with complex lipid profiles. However, the standardization of apoB detection has long been a core bottleneck restricting its widespread clinical application, as discrepancies in results between different methods and laboratories can biases in clinical decision-making. In recent years, the development of Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) technology has provided a solution for optimizing apoB standardization. Currently, International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is promoting the development of a primary reference measurement procedure based on mass spectrometry, aiming to achieve apoB standardization traceable to the International System of Units (SI). This review systematically outlines the clinical value of apoB, main detection methods, standardization challenges, and the application and prospects of LC-MS/MS in overcoming these challenges. We aim to provide insights for further optimizing apoB detection standardization.