COMPARISON OF IN-HOUSE DEVELOPED ELISA WITH HPLC FOR MEASUREMENT OF HBA1C

Abstract

In-house developed ELISA for HbA1c was evaluated in comparison with Bio-Rad D-10 Dual Program (HPLC). % HbA1c was estimated using said methods in 40 blood samples. Intra and inter assay coefficient of variation (CV) were in acceptable range i.e., <3%. HbA1c results obtained by two methods showed good correlation, (y = 0.8942x + 0.7229 R2 = 0.877). Sensitivity, specificity, positive, and negative predictive value for in-house ELISA classifying patients as controlled and uncontrolled diabetes against HPLC were recorded as 87%, 94.1%, 95.0%, and 93.8%, respectively, while accuracy of the test was 90.0%. In-house ELISA for HbA1c is not only accurate, cost effective and simple but also precise comparable to HPLC in deciding glycemic status of patients.

Keywords:

• Biorad D10 Dual Program
• glycated hemoglobin
• glycemic status
• HbA1c ELISA
• hemoglobin A1c
• HPLC

ACKNOWLEDGMENT

The authors gratefully acknowledge the support of the late Dr. Raymond Edwards, from NETRIA UK, who provided us with the reagents and technical advice for developing this assay. We are also thankful to Simon Packer (SCIPAC Ltd.) for supplying HbA1c controls free of cost.

Notes