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Adaptation of the Diazyme Direct Enzymatic HbA1c Assay for a microplate reader at room temperature

  • Ilkka Penttilä EMAIL logo , Karri Penttilä , Toivo Halonen , Kari Pulkki , Jukka Törrönen and Rainer Rauramaa
Published/Copyright: May 17, 2011
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Clinical Chemistry and Laboratory Medicine
From the journal Clinical Chemistry and Laboratory Medicine Volume 49 Issue 7

Abstract

Background: Measurement of hemoglobin A1c (HbA1c) is a key diagnostic criterion and a key parameter for the follow-up of the treatment of diabetes mellitus. Typically, immunochemical assays of HbA1c are performed in clinical chemistry analyzers. In this study, we applied the HbA1c assay on a microplate reader at room temperature.

Methods: HbA1c samples were measured using the Direct Enzymatic HbA1c Assay™ from Diazyme Laboratories (Poway, CA, USA) using a Plate Chameleon™ Microplate Reader (Hidex Co., Turku, Finland) according to the manufacturer's protocol and a modification of the method to room temperature. The Tosoh G7 HPLC method for HbA1c (Tosoh Co., Tokyo, Japan) was used as a comparative method.

Results: There was good correlation of HbA1c results when the assay was performed at room temperature (+22°C) compared with that at +37°C (r=0.987). The modified method was linear over the HbA1c range 4%–14%. Analysis of HbA1c results from 50 blood samples by the modified method showed good agreement with the HPLC method (r=0.990).

Conclusions: The modified Diazyme Direct Enzymatic HbA1c Assay™ appears to work as good at +22°C as that performed according to manufacturer's protocol at +37°C.

Keywords: diabetes; hemoglobin A1c; immunoassay; plate reader photometer
Corresponding author: Ilkka Penttilä, MD, PhD, Kuopio Research Institute of Exercise Medicine, Haapaniementie 16, 70100 Kuopio, Finland
Received: 2010-11-18
Accepted: 2011-2-6
Published Online: 2011-05-17
Published in Print: 2011-07-01

©2011 by Walter de Gruyter Berlin Boston

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https://doi.org/10.1515/CCLM.2011.186
Keywords for this article
diabetes; hemoglobin A1c; immunoassay; plate reader photometer

Articles in the same Issue

  1. Editorial
  2. Method comparison: where do we draw the line?
  3. Review
  4. Current role of liquid chromatography coupled to mass spectrometry in clinical toxicology screening methods
  5. Minireview
  6. Molecular diagnostics for pharmacogenomic testing of fluoropyrimidine based-therapy: costs, methods and applications
  7. Opinion Paper
  8. Preanalytical quality improvement: from dream to reality
  9. Point
  10. Towards more complete specifications for acceptable analytical performance – a plea for error grid analysis
  11. Counterpoint
  12. Closing the brain-to-brain loop in laboratory testing
  13. General Clinical Chemistry and Laboratory Medicine
  14. Harmonization of growth hormone measurements with different immunoassays by data adjustment
  15. Comparison of the results from two different External Quality Assessment Schemes supports the utility of robust quality specifications
  16. High-throughput LC-MS/MS method for monitoring sirolimus and everolimus in the routine clinical laboratory
  17. Performance of the Roche Total Mycophenolic Acid® assay on the Cobas Integra 400®, Cobas 6000® and comparison to LC-MS/MS in liver transplant patients
  18. Diagnostic efficiency of truncated area under the curve from 0 to 2 h (AUC0–2) of mycophenolic acid in kidney transplant recipients receiving mycophenolate mofetil and concomitant tacrolimus
  19. Good performance of an immunoassay based method for nevirapine measurements in human breast milk
  20. Measurement of plasma amino acids by Ultraperformance® Liquid Chromatography
  21. Interchangeability of blood gas, electrolyte and metabolite results measured with point-of-care, blood gas and core laboratory analyzers
  22. Granularity Index of the SYSMEX XE-5000 hematology analyzer as a replacement for manual microscopy of toxic granulation neutrophils in patients with inflammatory diseases
  23. Direct chromogenic substrate immuno-capture activity assay for testing of factor VII-activating protease
  24. The antinuclear antibody assay: developing criteria for reflexive anti-dsDNA antibody testing in a laboratory setting
  25. A simple liquid chromatography-tandem mass spectrometry method for measuring metanephrine and normetanephrine in urine
  26. Monoclonal gammopathy missed by capillary zone electrophoresis
  27. Adaptation of the Diazyme Direct Enzymatic HbA1c Assay for a microplate reader at room temperature
  28. Validation and Outcome Studies
  29. Laboratory assessment of iron status in pregnancy
  30. Cardiovascular Diseases
  31. Blood cells characteristics as determinants of acute myocardial infarction
  32. No evidence for an association between the rs2824292 variant at chromosome 21q21 and ventricular fibrillation during acute myocardial infarction in a German population
  33. Letters to the Editor
  34. Letter to the Editor Reply: Statistical methods for assessment of added usefulness of new biomarkers
  35. Reply to Vavrova et al. Clin Chem Lab Med 2011;49:89–92
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