Performance Evaluation of a New Fluorescent-Based Lateral Flow Immunoassay for Quantification of Hemoglobin A1c (HBA1c) in Diabetic Patients

Abstract

Background: Rapid hemoglobin A1C (HbA1c) level monitoring is essential in slowing the progression of 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 laboratories and population surveillance. Aim: We aim to evaluate the performance of Finecare™ HbA1c Rapid Test, certified by CE, NGSP, and IFCC, for the quantitative measurement of hemoglobin A1C (HbA1c) along with its reader. Methods: A total of 100 (fingerstick and venepuncture whole blood) samples were analyzed by Wondfo Finecare™ HbA1c Rapid Quantitative Test and the results were compared with the reference assay Cobas Pro c503. Results: A strong correlation was observed between Finecare™/Cobas Pro c503 with fingerstick (r > 0.93, p < 0.0001) and venous (r > 0.97, p < 0.0001) blood samples. Finecare™ measurements showed excellent agreement and compliance with Roche Cobas Pro c503 as the mean bias was negligible; 0.05 (Limits-of-agreement: -0.58-0.68) with fingerstick and 0.003 (Limits-of-agreement: -0.49-0.50) with venous blood. Interestingly, a very small mean bias (0.047) was also shown between the fingerstick and the venepuncture data, indicating that the type of sample used does not affect the results and the high reproducibility of the assay. Finecare™ showed 92.0% (95% CI: 74.0-99.0) sensitivity and 94.7% (95% CI: 86.9-98.5) specificity compared to the Roche Cobas Pro c503 using fingerstick whole blood samples. Finecare™ showed 100% (95% CI: 86.3-100) sensitivity and 98.7% (95% CI: 92.8-100) specificity compared to the Cobas Pro c503 using venepuncture samples. Cohen's Kappa denoted excellent agreement with Cobas Pro c503; 0.84 (95% CI: 0.72-0.97) and 0.97 (95% CI: 0.92-1.00) using fingerstick and venous blood samples, respectively. Most importantly, Finecare™ showed a significant difference between normal, pre-diabetic, and diabetic samples (p < 0.0001). Similar results were obtained when an additional 47 samples (from different participants; mainly diabetic) were analyzed in a different lab using different Finecare™ analyzer and different kit lot number. Conclusions: Finecare™ is a reliable and rapid assay (5 min) which can be easily implemented for long-term monitoring of HbA1c in diabetic patients, particularly in small laboratory settings.