Effects of beta thalassemia minor on results of six glycated hemoglobin methods

• Published in: Clinica chimica acta 2004-12, Vol.350 (1), p.123-128
• Main Authors: Polage, Christopher, Little, Randie R., Rohlfing, Curt L., Cole, Thomas G., Roberts, William L.
• Format: Article
• Language: English
• Subjects: Adult; Anemia; Beta thalassemia minor; beta-Thalassemia - metabolism; Biological Assay - methods; Diabetes Mellitus, Type 1 - blood; Evaluation Studies as Topic; False elevation; Glycated hemoglobin; Glycated Hemoglobin A - analysis; Glycated Hemoglobin A - metabolism; HbA 1c; Hematologic Tests - methods; Humans; Phenotype; Regression Analysis; Sensitivity and Specificity
• ISSN: 0009-8981; 1873-3492
• DOI: 10.1016/j.cccn.2004.07.015

Beta-thalassemia minor (BTM) is a common benign condition that can be present in patients with diabetes mellitus. There are conflicting reports about the effect of BTM on glycated hemoglobin (gHb) measurements. We evaluated 6 gHb methods using samples from non-diabetic subjects with BTM. Samples submitted for hemoglobin phenotype analysis were evaluated. A total of 57 samples (30 controls and 27 with BTM) from non-diabetic subjects were selected. GHb analysis was performed by Tosoh A1c 2.2+, Primus CLC 330, Bayer DCA 2000, Beckman Coulter, Synchron CX7 and LX20, and Roche Tina-quant II assays. The A1c 2.2+, CLC 330, DCA 2000 and Tina-quant II assays showed no statistically significant difference between the control and BTM groups. In contrast, BTM results were significantly higher than controls on the Synchron CX7 analyzer and borderline significant on the Synchron LX20 ( p=0.051). Further investigation demonstrated an increase in Synchron %HbA 1c results with decreasing hemoglobin concentrations. In this study using samples from subjects with normal or near-normal gHb, BTM does not affect gHb measurements per se. However, the Synchron methods yielded higher results for samples with lower hemoglobin concentrations, like those that can be seen in BTM. The Synchron method was improved at the end of 2003, which minimized this problem.