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

Monitoring 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. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement No. The funders had no role in study design and analysis, decision to publish, or preparation of the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Ethics Committee, Faculty of Medicine, Thammasat University (approval number 157/2564, project number MTU-EC-00-4-062/64). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All relevant data are within the manuscript and its Supporting Information files. * (HbA1c) : Glycated hemoglobin (POCT) : Point-of-Care Test (DM) : Diabetes mellitus (POCT-HbA1cMWCNTs/AuNPs) : Nanoparticle-based electrochemical biosensor – multiwalled nanotubes corporated with gold nanoparticles