Early diagnosis of heart failure using a fluorescent immunoassay based point of care NTproBNP test
D Gruson, A Khatib, A C PouleurAbstract
Background
NT-proBNP measurement is central to heart failure (HF) diagnosis and management. Robust point-of-care testing (POCT) solutions have the potential to accelerate triage and expand access to testing in primary care, emergency settings, and mobile health pathways. The evaluated novel POCT platform is a fluorescence immunoassay system delivering NT-proBNP results within 8 minutes and designed for decentralized use with minimal
Purpose
To evaluate the analytical performance, clinical agreement, and usability of the Wondfo Finecare™ FS-1000 NT-proBNP assay in comparison with a central laboratory reference method (Cobas 8000 e602)
Methods
Analytical precision was evaluated using three levels of quality control (QC) material (10 replicates per level over 5 consecutive days) with heparinized plasma. Method comparison was performed on 120 venous samples analyzed in parallel with the central laboratory method. Passing–Bablok regression, Bland–Altman analysis, and kappa agreement at key clinical thresholds (125 pg/mL and 1000 pg/mL) were computed. Usability was assessed by five independent operators according to predefined criteria covering device handling, workflow, training requirements, and operational constraints.
Results
The analytical evaluation showed acceptable precision across QC levels, with CVs of 6.1% at 128.7 pg/mL, 12.3% at 1337.9 pg/mL, and 8.4% at 6051.6 pg/mL. All mean biases were within the CLIA 2024 allowable total error of ±30%. Method comparison demonstrated strong correlation between the POCT platform and the reference method (Passing–Bablok: y = 0.98 + 1.12x; r = 0.98; p < 0.0001). Bland–Altman analysis showed a mean bias of +125.1 pg/mL (limits of agreement: −1347 to +1597 pg/mL). Agreement at clinical thresholds was very good, with kappa values of 0.76 at 125 pg/mL and 0.83 at 1000 pg/mL. Usability testing yielded an overall satisfactory rating, emphasizing the platform’s light weight (<5 kg), compact size (<30×30 cm), straightforward workflow, minimal training needs, and rapid 8-minute turnaround time.
Conclusion
This novel fluorescent immunoassay POCT NT-proBNP platform demonstrates strong analytical performance, high agreement with a validated laboratory method, and excellent usability by non-expert operators. Its portability, rapid turnaround, and ease of deployment support integration into community HF pathways, primary care environments, and mobile or near-patient diagnostic strategies.