Cardiology Research, ISSN 1923-2829 print, 1923-2837 online, Open Access
Article copyright, the authors; Journal compilation copyright, Cardiol Res and Elmer Press Inc
Journal website https://cr.elmerpub.com

Short Communication

Volume 16, Number 5, October 2025, pages 447-452

Evaluation of a Point-of-Care N-Terminal Pro-Brain Natriuretic Peptide Assay for Heart Failure Management

Figures

Figure 1.
Figure 1. Bland-Altman and Passing-Bablok for the LumiraDx Platform NT-proBNP assay with the first reagent lot. Bland-Altman (a) and Passing-Bablok (b) of values < 1,000 ng/L, for the NT-proBNP LumiraDx Platform assay compared with the gold standard Cobas e602 assay (n = 18). Bland-Altman (c) and Passing-Bablok (d) of values > 1,000 ng/L, for the NT-proBNP LumiraDx Platform assay compared with the gold standard Cobas e602 assay (n = 19). *The units are ng/L and % for Passing-Bablok and Bland-Altman, respectively. NT-proBNP: N-terminal pro-brain natriuretic peptide.
Figure 2.
Figure 2. Bland-Altman and Passing-Bablok for the LumiraDx Platform NT-proBNP assay with the second reagent lot. Bland-Altman (a) and Passing-Bablok (b) of values < 1,000 ng/L, for the NT-proBNP LumiraDx Platform assay compared with the gold standard Cobas e601 assay (n = 18). Bland-Altman (c) and Passing-Bablok (d) of values > 1,000 ng/L, for the NT-proBNP LumiraDx Platform assay compared with the gold standard Cobas e601 assay (n = 21). *The units are ng/L and % for Passing-Bablok and Bland-Altman, respectively. NT-proBNP: N-terminal pro-brain natriuretic peptide.

Tables

Table 1. Summary of Analytical Performance of the LumiraDx® NT-proBNP Assay
 
Reagent lotnMean bias (%)Passing-Bablok interceptPassing-Bablok slopeCorrelation coefficient (r)
CI: confidence interval; CV: coefficient of variation; NT-proBNP: N-terminal pro-brain natriuretic peptide; r: correlation coefficient.
Lot 1 (< 1,000 ng/L)18-6.1 (95% CI: -14.8 to 2.6)1.1 (95% CI: -21.8 to 14.4)0.96 (95% CI: 0.81 to 1.1)0.98
Lot 1 (> 1,000 ng/L)19-21.7 (95% CI: -33.4 to -9.9)391.4 (95% CI: -807.9 to 1304.4)0.71 (95% CI: 0.51 to 1.00)0.97
Lot 2 (< 1,000 ng/L)18-15.1 (95% CI: -23.1 to -7.0)-4.7 (95% CI: -27.8 to 30.6)0.88 (95% CI: 0.78 to 1.02)0.96
Lot 2 (> 1,000 ng/L)20-6.4 (95% CI: -17.0 to 4.2)-251.5 (95% CI: -939.4 to -23.6)1.06 (95% CI: 0.95 to 1.24)0.96

 

Table 2. User-Friendliness of the LumiraDx Platform NT-proBNP POCT Assay
 
CriteriaSatisfactory (S)Intermediary (I)Unsatisfactory (U)Results
NT-proBNP: N-terminal pro-brain natriuretic peptide; POCT: point-of-care testing.
Device weight< 5 kg5 kg < x < 10 kg>10 kgSSSSSSSSSSS
Device size< 5 × 5 cm5 × 5 cm < x < 30 × 30 cm30 × 30 cmIIIIIIIIIII
Additional equipment needed to perform the analysis (device, cartridges, consumables)No1 - 2> 3IIIIIIIUUUU
Description of the sample collection processYesIncompleteNoSSSSSSSSSSU
Description of the test processYesIncompleteNoSSSSSSSSSSS
Description of how the results are presentedYesIncompleteNoSSSSSSSSSSI
Function and use of the testYesIncompleteNoSSSSSSSSSII
Presence of the necessary instructions for the user to perform the test correctlyYesIncompleteNoSSSSSSSSSSI
Training required to collect samplesNoIncompleteYesSSSSSSSSSSU
Training required to use the deviceNoBasic trainingSpecial trainingSSSSSSSSIIU
Training necessary for the calibration and quality control of the deviceNoIncompleteYesSSSSSSSSSSS