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

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 byPOCT 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, theslope 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. (author)