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A Rapid and Chemical-free Hemoglobin Assay with Photothermal Angular Light Scattering
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Commutable whole blood reference materials for hemoglobin A1c validated on multiple clinical analyzers.

Hong Liu1, Lingkai Wong1, Sharon Yong1

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|December 14, 2018
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Summary
This summary is machine-generated.

New whole blood certified reference materials (CRMs) for hemoglobin A1c (HbA1c) were developed. These CRMs demonstrate good commutability across most clinical analyzers, aiding in accurate diabetes mellitus diagnosis and glycemic control monitoring.

Keywords:
certified reference materialcommutabilitydiabeteshemoglobin A1cisotope dilution mass spectrometry

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Area of Science:

  • Clinical Chemistry
  • Biomarker Measurement
  • Reference Materials

Background:

  • Accurate hemoglobin A1c (HbA1c) measurement is crucial for diabetes mellitus diagnosis and glycemic control.
  • Commutable whole blood certified reference materials (CRMs) are essential for validating HbA1c measurement methods and for quality control.

Purpose of the Study:

  • To develop and characterize hemolyzed whole blood CRMs for HbA1c.
  • To assess the commutability of these CRMs across various clinical analyzers.

Main Methods:

  • Development of three levels of hemolyzed whole blood CRMs for HbA1c.
  • Certification of values using liquid chromatography-isotope dilution tandem mass spectrometry (LC-IDMS/MS) with peptide standards.
  • Commutability assessment by comparing CRM and patient specimen measurements across six clinical analyzers using routine methods.

Main Results:

  • Certified values for the HbA1c CRMs were established at 35.1±2.0, 50.3±1.9, and 65.8±2.6 mmol/mol.
  • Good commutability was observed on five out of six clinical analyzers.
  • Poor commutability was noted on one analyzer, despite using a method similar to others with good commutability.

Conclusions:

  • The developed whole blood CRMs, with certified values traceable to metrological standards and good commutability on most analyzers, are suitable for HbA1c method validation and quality control.
  • The study highlights the critical importance of commutability testing using diverse clinical analyzers for the reliability of clinical CRMs.