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Correlation and Commutability Study between an LC-MS-Based Reference Measurement Procedure and Immunoassays Measuring
Ioannis Dikaios1, Christa M Cobbaert2, Vincent Delatour3
1European Commission, Joint Research Centre (JRC), Geel, Belgium.
Clinical Chemistry
|June 16, 2026
Summary
A new mass spectrometry reference system shows promise for standardizing apolipoprotein measurements. This improves cardiovascular risk prediction by ensuring accurate ApoA-I and ApoB levels, crucial for clinical diagnostics.
Area of Science:
- Clinical Chemistry
- Mass Spectrometry
- Cardiovascular Diagnostics
Background:
- Serum apolipoprotein A-I (ApoA-I) and apolipoprotein B (ApoB) predict cardiovascular events beyond traditional lipids.
- The IFCC Working Group is creating a mass spectrometry-based reference measurement system for apolipoproteins.
- This system includes a reference measurement procedure (RMP) and commutable reference materials (RMs).
Purpose of the Study:
- To evaluate a novel mass spectrometry-based reference measurement procedure (RMP) for apolipoprotein A-I (ApoA-I) and apolipoprotein B (ApoB).
- To assess the commutability of candidate reference materials (RMs) for harmonizing apolipoprotein measurements.
- To improve the accuracy and comparability of ApoA-I and ApoB measurements in clinical samples.
Main Methods:
- Compared a mass spectrometry-based RMP with 8 immunoassay methods using 30 clinical samples.
- Assessed the commutability of 8 candidate RMs and existing WHO-IFCC standards (SP1-01, SP3-08).
- Investigated agreement and potential noncommutability issues for ApoA-I and ApoB measurements.
Main Results:
- Immunoassay methods for ApoA-I and ApoB require further harmonization.
- The RMP correlated well with immunoassay methods for both ApoA-I and ApoB.
- Most candidate RMs showed good commutability for ApoA-I, but variability was observed for ApoB, with some standards exhibiting noncommutability.
Conclusions:
- A robust reference measurement system can significantly improve apolipoprotein measurement harmonization.
- The RMP demonstrates comparable selectivity to immunoassays for ApoA-I and ApoB.
- Future reference materials may require careful selection, potentially using single-donor samples for ApoB, to ensure commutability.
