Related Experiment Video
Updated: Jun 23, 2026
Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes
Published on: March 22, 2022
Analytical Evaluation of a Point-of-Care Platform for Glycated Hemoglobin and N-Terminal Pro-B-Type Natriuretic
Perrin Ngougni Pokem1,2, Ali Khatib3,2, Iman Azariouh Kaddouri4,5
1Department of Clinical Biochemistry, Cliniques Universitaires St-Luc and Universite Catholique de Louvain, Brussels, Belgium.
Insights
The AFIAS-3 point-of-care testing platform shows excellent accuracy for glycated hemoglobin (HbA1c) and acceptable accuracy for N-terminal pro-B-type natriuretic peptide (NT-proBNP). This dual biomarker POCT supports decentralized cardiometabolic diagnostics.
Area of Science:
- Cardiovascular diagnostics
- Diabetes management
- Point-of-care testing
Background:
- Heart failure is a common diabetes complication, necessitating integrated cardiometabolic assessment.
- Glycated hemoglobin (HbA1c) and NT-proBNP are key biomarkers for glycemic control and myocardial stress, respectively.
- Point-of-care testing (POCT) offers potential for decentralized diagnostics and reduced turnaround times.
Purpose of the Study:
- To evaluate the analytical performance of the AFIAS-3 POCT fluorescence immunoassay platform.
- To compare HbA1c and NT-proBNP measurements with established central laboratory methods.
Main Methods:
- A single-center verification study using 50 patient samples per analyte.
- Comparison of AFIAS-3 HbA1c with HPLC (Tosoh G8) and NT-proBNP with electrochemiluminescence immunoassay (cobas 8000).
- Assessment of analytical precision, accuracy, method agreement (Passing-Bablok, Bland-Altman, Spearman), and clinical threshold agreement (Cohen's kappa).
Main Results:
- AFIAS-3 demonstrated excellent precision for HbA1c (CVs 1.9%, 1.8%) with strong correlation (r=0.98) and minimal bias (-0.03%).
- Excellent agreement for HbA1c at the 6.5% diagnostic threshold (κ=0.92).
- High correlation for NT-proBNP (r=0.99) with substantial agreement at clinical thresholds, despite observed proportional bias at higher concentrations (CVs 5.3%, 15.4%; slope 1.24).
Conclusions:
- The AFIAS-3 POCT platform shows excellent analytical agreement for HbA1c.
- Acceptable agreement for NT-proBNP at clinically relevant thresholds supports its use in decentralized cardiometabolic diagnostics.
- NT-proBNP results from AFIAS-3 at higher concentrations require cautious interpretation.
Background:
Heart failure is a frequent complication of diabetes, highlighting the importance of integrated cardiometabolic assessment. Glycated hemoglobin (HbA1c) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) represent complementary biomarkers reflecting glycemic control and myocardial stress. Point-of-care testing (POCT) platforms may facilitate decentralized diagnostics and shorten analytical turnaround time. The aim of this study was to evaluate the analytical performance of the AFIAS-3 point-of-care fluorescence immunoassay platform for HbA1c and NT-proBNP measurements in comparison with established central laboratory methods.
Methods:
This single-center verification study included 50 patient samples for each analyte. HbA1c measurements obtained using AFIAS-3 were compared with Tosoh G8 high-performance liquid chromatography (HPLC), while NT-proBNP measurements were compared with the cobas 8000 electrochemiluminescence immunoassay. Analytical precision and accuracy were assessed using manufacturer quality control materials. Method comparison was performed using Passing-Bablok regression, Bland-Altman analysis, and Spearman correlation. Agreement at clinical thresholds was evaluated using Cohen's kappa statistics.
Results:
For HbA1c, analytical precision was excellent, with coefficients of variation of 1.9% and 1.8%. Correlation with the reference method was strong (r = 0.98), and the mean bias was minimal (-0.03%). Agreement at the diagnostic threshold of 6.5% was excellent (κ = 0.92). For NT-proBNP, coefficients of variation were 5.3% and 15.4%. Correlation with the central laboratory method was very high (r = 0.99), although proportional bias was observed at higher concentrations (slope 1.24). Agreement at clinically relevant thresholds remained substantial.
Conclusions:
The AFIAS-3 POCT platform demonstrated excellent analytical agreement for HbA1c and acceptable agreement for NT-proBNP at clinically relevant thresholds. Dual biomarker POCT may support decentralized cardiometabolic diagnostics, although NT-proBNP values at higher concentrations should be interpreted cautiously.
Related Concept Videos
01:19Blood Studies for Cardiovascular System II: CRP, Hcy, and Cardiac Natriuretic Peptide Markers
These markers indicate stress or strain on the heart muscle:
Natriuretic Peptides (BNP)
Cardiac myocytes produce these hormones in response to ventricular stretching...
01:29Hyperglycemia