Comparative Analysis of Manual and Automated (HbA1c) Methods in β-Thalassemia Carriers with Diabetes

<ns3:p>Background Hemoglobin A1c is widely recognized as an indicator of long-term glucose control in patients with diabetes. Its measurement, however, can be influenced by several hemoglobin disorders, including the β-thalassemia trait, which is relatively common in the Middle East. Methods This work compared manual HbA1c testing procedures with an automated high-performance liquid chromatography (HPLC) technique in diabetic patients carrying the β-thalassemia trait. Sixty diagnosed diabetic cases with confirmed β-thalassemia were included from Fallujah Teaching Hospital. HbA1c was analyzed by three procedures: Variant II HPLC, ion-exchange resin, and Turbidimetric immunoassay. Data were processed using ANOVA, t-test, and Pearson correlation in SPSS, considering p &lt; 0.05 significant. Results Differences among the tested methods were clearly evident. Measurements obtained by the automated HPLC system were generally higher mean (9.2%) than those recorded with the Turbidimetric immunoassay (7.58%) and the ion-exchange resin technique (7.96%). The observed gap between automated and manual estimations, reaching 1.5% and 1.15% respectively, was found to be statistically significant. HbA1c values demonstrated a strong positive correlation with HbA values in all three analytical methods (r &gt; 0.82, p &lt; 0.001). Conclusions These results suggest that manual assays would be expected to erroneously underestimate HbA1c levels in β-thalassemia carriers, which could significantly affect its clinical interpretation. The NGSP-standardized HPLC method was the most reliable for the accurate measurement of HbA1c and reflects more precisely glycemic control in patients with variant haemoglobins.</ns3:p>