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Current 25-hydroxyvitamin D assays: do they pass the test?

Lizhen Ong1, Sharon Saw, Noorulhijjah Bte Sahabdeen

  • 1Department of Laboratory Medicine, National University Hospital, Singapore 119074, Singapore. lizhen_ong@nuhs.edu.sg

Clinica Chimica Acta; International Journal of Clinical Chemistry
|April 3, 2012
PubMed
Summary

Accurate vitamin D testing is crucial for diagnosing deficiencies and related diseases. Current automated assays show significant bias and do not meet analytical goals, hindering reliable patient diagnosis and monitoring.

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Area of Science:

  • Clinical Chemistry
  • Biochemistry
  • Analytical Chemistry

Background:

  • Vitamin D insufficiency is linked to metabolic diseases and immunodeficiencies.
  • Accurate vitamin D testing is essential for diagnosis and monitoring.
  • Existing 25-hydroxyvitamin D (25OHD) assays lack comparability to reference methods.

Purpose of the Study:

  • To evaluate the accuracy of automated 25OHD assays against a Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) reference method.
  • To assess assay performance based on established analytical goals for precision and bias.

Main Methods:

  • Comparison of three automated assays (Roche, Abbott, Advia) and one Radioimmunoassay (Diasorin) with LC-MS/MS.
  • Analysis of assay accuracy using Passing Bablok regression, bias assessment, and measurement of uncertainty.

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Main Results:

  • Good correlation (slopes 0.95-1.31) observed, but significant positive bias in Abbott and Diasorin assays.
  • Most methods failed to meet analytical goals (CV <10%, bias <5%).
  • Assays met uncertainty criteria with quality control materials but not patient samples.

Conclusions:

  • Assay inadequacies stem from variations in vitamin D extraction, cross-reactivities, matrix interferences, and lack of standardization.
  • Current automated 25OHD assays require improvement for reliable clinical use.
  • Standardization is needed to ensure accurate vitamin D deficiency diagnosis and monitoring.