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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
PubMed
Summary
This summary is machine-generated.

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.

Keywords:
LC-MS/MScommutabilityexternal quality assessmentimmunoassaysreference materialsserum folate

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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.