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Standardization Challenges and Breakthroughs in Apolipoprotein B Detection: From Immunoassays to LC-MS/MS
Anqi Pan1,2, Haijian Zhao1, Jing Wang1
1National Center for Clinical Laboratories, Beijing Hospital, National Center for Gerontology; National Clinical Research Center for Gerontology; The Key Laboratory of Geriatrics of NHC; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, PR China.
Apolipoprotein B (apoB) is crucial for assessing atherosclerotic cardiovascular disease (ASCVD) risk. Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) offers a path to standardize apoB measurements, improving clinical decision-making.
Area of Science:
- Clinical Chemistry
- Biomarker Analysis
- Mass Spectrometry
Background:
- Apolipoprotein B (apoB) is a vital biomarker for atherosclerotic cardiovascular disease (ASCVD) risk assessment and treatment monitoring.
- Its predictive value for ASCVD risk surpasses traditional lipid indicators, especially in complex lipid profiles.
- Standardization of apoB detection methods remains a significant challenge, leading to result discrepancies and potential biases in clinical decisions.
Purpose of the Study:
- To review the clinical significance of apoB in ASCVD.
- To discuss current apoB detection methodologies and their standardization challenges.
- To explore the application and future potential of Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for apoB standardization.
Main Methods:
- Systematic review of existing literature on apoB clinical value and detection methods.
- Analysis of standardization issues in apoB immunoassays and other techniques.
- Evaluation of LC-MS/MS as a reference measurement procedure for apoB.
Main Results:
- apoB is a superior biomarker for ASCVD risk compared to conventional lipids.
- Existing apoB detection methods lack standardization, hindering clinical application.
- LC-MS/MS technology shows promise for developing a standardized, SI-traceable apoB measurement procedure.
Conclusions:
- Standardized apoB measurements are essential for accurate ASCVD risk assessment and treatment monitoring.
- LC-MS/MS offers a viable technological solution to address current standardization challenges.
- Further development of mass spectrometry-based methods by organizations like IFCC is key to achieving global apoB standardization.

