Analytical verification, usability, and clinical suitability of a whole-blood point of care NTproBNP assay for rapid heart failure assessment
D Gruson, A Khatib, A C PouleurAbstract
Background
Early diagnosis of heart failure (HF) remains challenging in acute and ambulatory settings, where timely clinical decision-making is essential. While NT-proBNP is a cornerstone biomarker for HF assessment, delays related to sample transport and laboratory workflows may limit its clinical impact. Whole-blood point-of-care testing (POCT) offers the potential to accelerate HF rule-in/rule-out strategies, provided that analytical performance, usability, and operational integration are compatible with real-world practice.
Purpose
To verify the analytical performance of a whole-blood POCT NT-proBNP assay, assess its agreement with a central laboratory method, and evaluate usability and operational suitability for rapid HF assessment in clinical settings.
Methods
Analytical precision of the Quidel Triage® True NT-proBNP POCT assay was evaluated using three levels of quality control material (10 replicates per level over five consecutive days). Method comparison was performed on 39 patient samples analyzed in parallel with a central laboratory NT-proBNP immunoassay, using Passing–Bablok regression and Bland–Altman analysis. Usability was assessed by five independent operators using predefined criteria covering device handling, workflow complexity, training requirements, clarity of instructions, and operational constraints in near-patient testing environments.
Results
The POCT NT-proBNP assay demonstrated acceptable analytical imprecision, with a CV of 10.8% at 142 ng/L and a bias of 2.41%. NT-proBNP concentrations ranged from 96 to 23555 ng/L. Method comparison showed strong agreement with the central laboratory assay (Passing–Bablok: y = −75.26 + 1.086x; r = 0.92; p < 0.0001), with a mean bias of 441.4 ng/L on Bland–Altman analysis. The system provided quantitative NT-proBNP results from whole blood in less than 18 minutes, without centrifugation or dedicated laboratory infrastructure. Usability evaluation yielded overall satisfactory ratings across key domains, highlighting intuitive operation, limited additional equipment requirements, minimal training needs, and suitability for use by non-laboratory staff in decentralized settings.
Conclusion
The verified analytical performance, strong agreement with a central laboratory method, and favorable usability profile support the clinical suitability of whole-blood POCT NT-proBNP testing. Rapid turnaround time combined with operational simplicity makes this approach compatible with hospital, ambulatory, and decentralized care pathways, enabling earlier HF assessment and faster clinical decision-making in patients with suspected heart failure.