COMPARISON OF POINT-OF-CARE HEMOGLOBIN A1C TESTING WITH CENTRAL LABORATORY METHOD FOR ITS USE IN SCREENING AND MONITORING OF DIABETES MELLITUS IN A RESOURCE-CONSTRAINED SETTING

Abstract

Objective: The aim of this study is to evaluate the analytical performance of the Point-Of-Care Testing HbA1c analyzer for its use as an alternate to the central/core laboratory method. Material and Methods: This was a cross-sectional study in which 176 samples of HbA1c were analyzed by POCT HbA1c analyzer (A1C EZ 2.0) and central laboratory analyzer (Cobas 6000) as comparative instrument. Results: Based on the Bland-Altman plot, the HbA1c level for 164 out of 176 (93.18%) subjects analyzed by the POCT-HbA1c was within the range of the 95% limit of agreement. The area under the receiver operating characteristic (ROC) curve for clinical diagnosis of diabetes was 0.91. The sensitivity and specificity for HbA1c POCT were 94.5% and 88.0%. Using regression analysis, the slope of the A1C EZ 2.0 vs the Cobas 6000 Analyzer was 0.934, with an intercept of 0.20 and a correlation coefficient of 0.97. Conclusion: This study concludes that the POCT-HbA1c analyzer is a suitable replacement for central/core laboratory HbA1c measurement. It is useful for screening and monitoring of diabetes mellitus in certain situations especially in a resource constraint setting. Keywords: Diabetes mellitus, Screening, Monitoring, HbA1c, Point-of-care testing