A comparative analysis of Point of care lateral flow immune assay (LFA) with routine and optimized laboratory assays for the detection of HbA1c levels in a human whole blood specimen

Abstract

The present study was aimed to compare the HbA1c point of care LFA test kit with routine and clinically proven, optimized methods for detection of HbA1c in whole blood samples. A total of 90 samples from patients with DM tested with newly developed LFA test kit and other analytical techniques. The results were analyzed for comparison and correlation of the HbA1c values to classify DM patients according to their glycemic control. Through regression analysis, the correlations between the results of HbA1c LFA and Alere HbA1c kit was found to be R2= 0.977 and for the HbA1c LFA and Biohermes A1CEZ kit was found to be R2= 0.980. The correlation between HbA1c LFA and ERBA Glycohemoglobin kit was found to be R2= 0.965 and for the HbA1c LFA and BIO-RAD variant HbA1c kit (HPLC) was found to be R2= 0.911. Based on the results obtained so far through newly developed LFA, compared with gold standard and other optimized methods. The LFA has proved to be rapid, simple, inexpensive, the point of care method with excellent sensitivity and specificity.