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A candidate reference method and multiple commutable control materials for serum 25-hydroxyvitamin D measurement.

Li Zhang1, Qichen Long1, Jiangtao Zhang2

  • 1National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing Engineering Research Center of Laboratory Medicine, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Journal of Clinical Laboratory Analysis
|November 13, 2022
PubMed
Summary
This summary is machine-generated.

A new reference method for measuring serum 25-hydroxyvitamin D (25(OH)D) is precise and accurate. This method ensures control materials are interchangeable for liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays, aiding standardization.

Keywords:
25-hydroxyvitamin Daccuracy-based external quality assessmentcommutabilitycontrol materialsliquid chromatography-tandem mass spectrometryreference method

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Area of Science:

  • Clinical Chemistry
  • Analytical Chemistry
  • Mass Spectrometry

Background:

  • Accurate measurement of serum 25-hydroxyvitamin D (25(OH)D) is crucial for clinical diagnosis and management.
  • Standardization of 25(OH)D assays is challenging due to method variability.
  • Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is a preferred analytical technique for 25(OH)D quantification.

Purpose of the Study:

  • To establish a reliable candidate reference method for serum 25(OH)D measurement.
  • To evaluate the commutability of various control materials across different LC-MS/MS methods.
  • To support the standardization of serum 25(OH)D analysis.

Main Methods:

  • Serum 25(OH)D2 and 25(OH)D3 were extracted and analyzed using LC-MS/MS.
  • Commutability was assessed following the CLSI EP14-A3 protocol.
  • Measurements were performed on diverse materials including serum pools, spiked samples, commercial controls, and external quality assessment materials using the candidate method and two routine LC-MS/MS methods.

Main Results:

  • The candidate reference method demonstrated complete separation of 25(OH)D2 and 25(OH)D3 from interfering compounds within a 9-minute analysis time.
  • High method precision was achieved, with results on NIST SRM 972a aligning with certified values.
  • All tested control materials exhibited commutability across the evaluated LC-MS/MS methods.

Conclusions:

  • The developed candidate reference method is precise, accurate, and robust, providing a reliable basis for routine 25(OH)D measurements.
  • The commutability of alternative control materials facilitates standardization efforts for serum 25(OH)D analysis.
  • This work contributes to improving the accuracy and consistency of vitamin D testing.