Estimation of Glycated Haemoglobin by Nephelometry, Ion Exchange Resin and High Performance Liquid Chromatography: A Cross-sectional Study

• Main Authors: Mangalore Balakrishna Prathima, Shridhar Reshma, Sushith, Prathiksha Shetty, D’Sa Janice, Bhuvanesh Sukhlal Kalal, Gopal R Madan
• Format: Article
• Language: English
• Published: JCDR Research and Publications Private Limited 2020-09-01
• Series: Journal of Clinical and Diagnostic Research
• Subjects: diabetes mellitus; enzymatic assay; india; test performance
• Online Access: https://jcdr.net/articles/PDF/13968/44408_CE[Ra1]_F(SHU)_PF1(AG_KM)_PFA(KM)_PB(AG_KM)_PN(SL).pdf

ABSTRACT Introduction: Diabetes mellitus cases are continually rising all over the world. Glycated haemoglobin (HbA1c) used as a diagnostic test to measure long-term average glycaemic control in diabetic patients. Aim: To assess the precision and reproducibility of the Ion Exchange Column Chromatography Resin (IECR) method and nephelometry in comparison to High-Performance Liquid Chromatography (HPLC) with respect to the estimation of HbA1c. Materials and Methods: A cross-sectional comparative study was conducted on 50 blood samples, collected from the diabetic subjects at the Department of Biochemistry and their HbA1c values were estimated by HPLC based BioRad D-10, nephelometry and IECR techniques. HPLC was used as a gold standard method, to evaluate the sensitivity and specificity of nephelometry and IECR techniques. Data were expressed as mean±standard deviation and intraclass Correlation Coefficient and Pearson correlation were calculated. Results: The mean age of the study subjects was 53.06±7.67 years. The mean plasma HbA1c levels were 8.16±2.9, 7.62±2.5 and 7.84±2.5 and mean estimated Average Glucose (eAG) was 187.00±84.4, 172.0±76.8, and 289.46±199.9 by HPLC, Nephelometry and IECR, respectively. Compared with HPLC, nephelometry had excellent correlation (r-value 0.925); p<0.001) and IECR (r-value 0.869; p<0.001). Conclusion: Nephelometry and IECR both had better performance and showed a greater concordance with gold standard HPLC. Therefore, nephelometry and IECR can be used as an alternative assay for HbA1c estimation.