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.