Performance evaluation of new fluorescent-based lateral flow immunoassay for quantification of HbA1c in diabetic patients

Background Rapid and constant HbA1c level monitoring is essential in slowing the progression of Type 2 diabetes. This need becomes challenging in low resources countries where the social burden of the disease is overwhelming. Recently, fluorescent-based lateral flow immunoassays (LFIAs) gained wide attention for small or non-laboratory settings and population surveillance. Aim This study aim to evaluate the performance of novel fluorescence-based LFIA Finecare™ HbA1c Rapid Quantitative Test for quantitative measurement of HbA1c along with its reader (Model No. FS-113). Methods We conducted a retrospective study using 147 samples (fingerstick and venepuncture whole blood samples) analysed by Finecare™ HbA1c Rapid Quantitative Test. For validating Finecare™ measurements, results were compared with results of the reference assay: Roche Cobas Pro c 503. Results Finecare™ showed 92.7% sensitivity and 94.7% specificity compared to the Roche Cobas Pro c 503 using fingerstick whole blood samples. On the other hand, Finecare™ showed 98.7% sensitivity and 100% specificity compared to the Roche Cobas Pro c 503 using venepuncture blood samples. Cohen’s Kappa statistic denoted excellent agreement with Roche Cobas Pro c 503, with values being 0.84 (95% CI: 0.72-0.97) and 0.97 (95% CI: 0.92-1.00) using fingerstick whole blood samples and venous blood, respectively. In addition, a strong correlation was observed between Finecare™/Roche Cobas Pro c 503 ( r> 0.9, p <0.0001) with fingerstick and venous blood samples. Most importantly, Finecare™ showed a significant difference between the normal, pre-diabetic, and diabetic samples ( p <0.001). Conclusion Finecare™ is a reliable assay and can be easily implemented for long-term monitoring of HbA1c in diabetic patients, particularly in none or small laboratory settings. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study did not receive any funding ### 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: Ethics committee/IRB of Qatar University waived ethical approval for this work 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 data produced in the present work are contained in the manuscript