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Exploring commutable materials for serum folate measurement: challenges in cross-method harmonization
Xiaerbanu Nizhamuding1,2, Qian Zhang3, Lizi Jin1,2
1National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, P.R. China.
Clinical Chemistry and Laboratory Medicine
|June 25, 2025
Summary
Reference materials (RMs) are crucial for accurate folate measurements. This study identified commutable RMs, with cRM-3 showing the best performance across diverse assays, improving clinical diagnostics.
Area of Science:
- Clinical Chemistry
- Metrology
- Analytical Chemistry
Background:
- Commutability of reference materials (RMs) is essential for accurate and equivalent analytical results across different measurement systems.
- In folate quantification, commutable RMs ensure that analytical behavior mirrors native clinical specimens across various detection platforms.
- Harmonization and metrological traceability of serum folate measurements are critical for reliable clinical diagnostics.
Purpose of the Study:
- To identify and characterize commutable candidate reference materials for serum folate assays.
- To enhance the harmonization and metrological traceability of folate measurements in clinical diagnostics.
Main Methods:
- Two isotope-dilution liquid chromatography tandem mass spectrometry (ID-LC-MS/MS) methods and three immunoassays were used across four laboratories.
- Thirty study materials, including pooled clinical serum samples and various reference materials, were assessed.
- Deming regression analysis and difference-in-bias approach evaluated commutability.
Main Results:
- Candidate RM 3 (cRM-3) demonstrated commutability across all tested assays, identifying it as the most suitable candidate.
- Seven materials, including cRM-1, cRM-2, and cRM-3, were found to be commutable for both ID-LC-MS/MS methods, irrespective of the statistical approach used.
Conclusions:
- The complexity of serum folate species and differing detection principles between immunoassays and ID-LC-MS/MS methods pose challenges to measurement harmonization.
- Variations in calibration substrates among immunoassays further complicate commutability assessment for folate measurements.
- Identifying commutable RMs like cRM-3 is vital for standardizing serum folate quantification and improving clinical laboratory results.
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