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Related Experiment Videos

Glycated hemoglobin measurement: intermethod comparison.

E Matteucci1, V Cinapri, L Rossi

  • 1Department of Internal Medicine, University of Pisa, a Italy. ematteuc@int.med.unipi.it

Diabetes, Nutrition & Metabolism
|November 22, 2001
PubMed
Summary
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Accurate interpretation of HbA1c results requires understanding analytical variations. An automated immunoturbidimetric assay offers a precise and reproducible alternative to HPLC for measuring HbA1c.

Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Analytical Chemistry

Background:

  • Clinical interpretation of serial HbA1c measurements depends on understanding pre-analytical, analytical, and intra-individual variations.
  • Total analytical error dictates the detectable change in HbA1c percentage.
  • Previous studies identified issues with routine High-Performance Liquid Chromatography (HPLC) use.

Purpose of the Study:

  • To compare a highly automated glycohemoglobin assay with the reference HPLC method.
  • To address problems identified in the routine use of HPLC for HbA1c measurement.

Main Methods:

  • Comparison of an immunoturbidimetric assay with HPLC for HbA1c determination.
  • Evaluation of within- and between-run coefficients of variation for both methods.

Related Experiment Videos

  • Analysis of 106 blood samples using both assays over 20 consecutive days.

    • Main Results:

    • HPLC showed coefficients of variation ranging from 0.86-0.93% (within-run) and 2.51-2.12% (between-run).
    • The immunoturbidimetric assay demonstrated coefficients of variation from 1.07-0.95% (within-run) and 1.61-0.99% (between-run).
    • A minor but significant bias towards lower HbA1c values was observed with the immunoturbidimetric assay (p<0.0001), with high correlation (r=0.96, p<0.0001).

    Conclusions:

    • The immunoturbidimetric assay is accurate, precise, and reproducible.
    • This assay represents a valid alternative to the reference HPLC method for HbA1c measurement.