Comparison of NGSP Certified Methods and their Cost Analysis for Estimation of HbA1c- A Cross-sectional Study

Abstract

Introduction: Diabetes Mellitus (DM) is a major non communicable disease that adversely impacts the health of the global community, contributing significantly to mortality. Estimation of glycated haemoglobin (HbA1c) is an integral component of diagnosis, treatment and follow-up of cases of DM as the various protocols have included it for therapy. In order to regularise the estimation of HbA1c, it is mandated by American Diabetes Association (ADA) to perform the test on NGSP certified methods only. Aim: To compare the results of HbA1c analysis by SIEMENS DIMENSION EXL 200 and BIORAD D-10 (NGSP certified methods). Materials and Methods: This was a cross-sectional observational study done in Department of Biochemistry, Armed Forces Medical College, Pune, Maharashtra, a tertiary care center. One hundred and twenty blood samples in EDTA tubes for haemoglobin variant analysis, received from patients with unexplained anaemia or screening for antenatal care were included in the study. The tests for HbA1c were performed by HPLC based BIORAD D10 and enzymatic based method, SIEMENS DIMENSION EXL 200 analyser. Cost analysis of both the methods was also performed. Students paired t-test was done to look for any significant statistical difference. Kappa coefficient was also calculated to analyse for agreement between values. Results: HbA1c estimation by SIEMENS DIMENSION EXL200 and BIORAD D-10 (both NGSP certified) showed marginally different results, but it was not significant enough to make a clinical difference (5.308% on BIORAD D10 and 5.211% on SIEMENS DIMENSION EXL 200). On performing the cost analysis, there was a significant difference observed with a figure of Rs 476.05/- per test on the SIEMENS DIMENSION EXL200, while it was significantly cheaper at Rs 266/- per test on the BIORAD D10. Conclusion: Estimation of HbA1c on SIEMENS DIMENSION EXL200 and BIORAD D10 was not clinically significant. As per cost analysis, BIORAD D10 is a cheaper alternative and suitable for tertiary care or large volume centres.