Electrochemical-biosensor Microchip Based on Gold Nanoparticles as a Point-of-Care Test (POCT) for Quantitative Determination of Glycated Hemoglobin (HbA1c)

Abstract

AbstractMonitoring the level of glycated hemoglobin (HbA1c) has become the gold standard measure of diabetes mellitus diagnosis and control in conjunction with FBG and oral glucose tolerance test. The study aimed to investigate the applicability of the newly developed nanoparticle-based electrochemical biosensor – multiwalled nanotubes corporated with gold nanoparticles (POCT-HbA1cMWCNTs/AuNPs) as a routine POCT for detection of HbA1c for the diagnosis of diabetes mellitus (DM). Finger-prick and venous blood samples were collected 108 DM and 98 non-DM subjects for determination of HbA1c and total hemoglobin by POCT-HbA1cMWCNTs/AuNPs in comparison with standard HPLC method. The performance of the POCT-HbA1cMWCNTs/AuNPs was evaluated using the standard cut-off HbA1c level of >6.5%. The sensitivity, specificity, positive predictive value, and negative predictive value of the test were 100.00%, 90.32%, 87.23%, and 100.00%, respectively. The probability of DM diagnosis in a subject with HbA1c >6.5 (positive predictive value) was 87.23% (82/94). The accuracy of the POCT-HbA1cMWCNTs/AuNPs was 94.18%, with %DMV (deviation of the mean value) of 0.25%. The results indicate satisfactory assay performance and applicability of the POCT-HbA1cMWCNTs/AuNPs for diagnosis of DM using the cut-off criteria of HbA1c >6.5.