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Clinical Chemistry 54: 1277-1282, 2008. First published June 12, 2008; 10.1373/clinchem.2008.103580
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Right arrow Endocrinology and Metabolism
(Clinical Chemistry. 2008;54:1277-1282.)
© 2008 American Association for Clinical Chemistry, Inc.

Endocrinology and Metabolism

Effects of Hemoglobin (Hb) E and HbD Traits on Measurements of Glycated Hb (HbA1c) by 23 Methods

Randie R. Little1,a, Curt L. Rohlfing1, Steve Hanson1, Shawn Connolly1, Trefor Higgins2, Cas W. Weykamp3, Mario D'Costa4, Veronica Luzzi5, William E. Owen6 and William L. Roberts7

1 Departments of Pathology & Anatomical Sciences and Child Health, University of Missouri–Columbia School of Medicine, Columbia, MO; 2 DynaLIFEDX, Edmonton, Canada; 3 Queen Beatrix Hospital, Winterswijk, The Netherlands; 4 Department of Laboratory Medicine, St. Joseph’s Health Centre, Toronto, Canada; 5 Core Laboratory for Clinical Studies, Washington University School of Medicine, St. Louis, MO; 6 ARUP Institute for Clinical & Experimental Pathology, Salt Lake City, UT; 7 Department of Pathology, University of Utah, Salt Lake City, UT.

aAddress correspondence to this author at: Diabetes Diagnostic Laboratory M767, Department of Pathology & Anatomical Sciences, University of Missouri–Columbia School of Medicine, One Hospital Drive, Columbia, MO 65212. E-mail littler{at}health.missouri.edu.

Background: Glycohemoglobin (GHB), reported as hemoglobin (Hb) A1c, is a marker of long-term glycemic control in patients with diabetes and is directly related to risk for diabetic complications. HbE and HbD are the second and fourth most common Hb variants worldwide. We investigated the accuracy of HbA1c measurement in the presence of HbE and/or HbD traits.

Methods: We evaluated 23 HbA1c methods; 9 were immunoassay methods, 10 were ion-exchange HPLC methods, and 4 were capillary electrophoresis, affinity chromatography, or enzymatic methods. An overall test of coincidence of 2 least-squares linear regression lines was performed to determine whether the presence of HbE or HbD traits caused a statistically significant difference from HbAA results relative to the boronate affinity HPLC comparative method. Deming regression analysis was performed to determine whether the presence of these traits produced a clinically significant effect on HbA1c results with the use of ±10% relative bias at 6% and 9% HbA1c as evaluation limits.

Results: Statistically significant differences were found in more than half of the methods tested. Only 22% and 13% showed clinically significant interference for HbE and HbD traits, respectively.

Conclusions: Some current HbA1c methods show clinically significant interferences with samples containing HbE or HbD traits. To avoid reporting of inaccurate results, ion-exchange chromatograms must be carefully examined to identify possible interference from these Hb variants. For some methods, manufacturers’ instructions do not provide adequate information for making correct decisions about reporting results.






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