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

Abstract 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 FinecareTM 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 FinecareTM HbA1c Rapid Quantitative Test. For validating FinecareTM measurements, results were compared with results of the reference assay: Roche Cobas Pro c 503. Results: FinecareTM 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, FinecareTM 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 FinecareTM/Roche Cobas Pro c 503 (r>0.9, p<0.0001) with fingerstick and venous blood samples. Most importantly, FinecareTM showed a significant difference between the normal, pre-diabetic, and diabetic samples (p<0.001). Conclusion: FinecareTM 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.