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

⁷ Department of Biology, Chemistry and Environmental Sciences, College of Arts and Sciences, American University of Sharjah, 26666 Sharjah, United Arab Emirates

⁸ Department of Pediatrics and Neonatology, Neonatal Intensive Care Unit, Newborn Screening Unit, Women's Wellness and Research Center, Hamad Medical Corporation, 3050 Doha, Qatar

⁹ Genomics and Precision Medicine (GPM), College of Health & Life Science (CHLS), Hamad Bin Khalifa University (HBKU), 34110 Doha, Qatar

¹⁰ Department of Research, Women’s Wellness and Research Center, Hamad Medical Corporation, 3050 Doha, Qatar

¹¹ Interim Translational Research Institute (iTRI), Hamad Medical Corporation (HMC), 3050 Doha, Qatar

¹² School of Life Science, Pharmacy and Chemistry, Faculty of Science, Engineering & Computing, Kingston University, KT1 1LQ London, UK

^*Correspondence: gheyath.nasrallah@qu.edu.qa (Gheyath K. Nasrallah)

Front. Biosci. (Landmark Ed) 2023, 28(3), 60; https://doi.org/10.31083/j.fbl2803060

Submitted: 15 February 2023 | Revised: 28 February 2023 | Accepted: 7 March 2023 | Published: 23 March 2023

(This article belongs to the Special Issue Cardiovascular Biomarkers)

This is an open access article under the CC BY 4.0 license.

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.

Keywords

serology

lateral flow immunoassay

LFIA

HbA1c

diabetes

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Fig. 1.

Pairwise correlation and linear regression analysis for each assay. (A) Correlation plot of Finecare ${}^{\text{TM}}$ with Cobas Pro c503 using fingerstick blood sample; (B) Correlation plot of Finecare ${}^{\text{TM}}$ with Cobas Pro c503 using venous whole blood sample; and (C) Correlation plot of Fingerstick blood sample with venous whole blood sample using Finecare ${}^{\text{TM}}$ machine. Spearman correlation coefficient (r) and p-value were indicated. The coefficient of determination (R ${}^{2}$ ) was calculated to be 0.95, 0.97, 0.94 for (A–C), respectively. n = 100.

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