Abstract
BACKGROUND AND OBJECTIVES: Brain natriuretic peptide (BNP) and N-terminal prohormone of BNP (NT-proBNP) are important biomarkers in pulmonary arterial hypertension (PAH). However, results are rarely available at the time of clinical assessment. The reliability of NT-proBNP/BNP point-of-care tests (POCT) in PAH patients and the stability of NT-proBNP in posted blood samples, to simulate remote monitoring, was investigated. METHODS: Group 1 PAH patients were prospectively recruited. A sample of 40 was required to demonstrate an intraclass correlation coefficient (ICC) of 0.94 with a 95% confidence interval width of < 0.1 for agreement between POCT and the laboratory standard. Blood samples were taken at two time-points for laboratory and POCT NT-proBNP/BNP. Separate samples were returned to the laboratory by post and some samples were assessed pre- and post-exercise assessing the impact of exercise. RESULTS: Forty-one patients were enrolled with 56 study visits. NT-proBNP laboratory and POCT (n = 50) provided equivalent test results (Passing-Bablok slope = 1.08, CI = 0.97-1.19, intercept = 18.22, CI = -41.6 to 4.5) and ICC = 0.97. However, laboratory and POCT BNP (n = 49), showed non-equivalence (Passing-Bablok slope = 1.24, CI 1.11-1.31, intercept = -5.11, CI = -9.4 to -0.46), ICC = 0.96. POCT NT-proBNP/BNP correctly classified 92% and 86% of cases, respectively against COMPERA 2.0 4-risk-strata thresholds. NT-proBNP postal laboratory samples and immediately processed NT-proBNP laboratory samples showed good agreement and exercise had no clinically significant effect on NT-proBNP/BNP results. Laboratory BNP identified fewer patients as high risk compared to NT-proBNP. BNP and NT-proBNP risk status agreed at only 57% of visits (p < 0.0009). CONCLUSIONS: These data support the use of POCT NT-proBNP as a rapidly accessible and reliable alternative in clinical settings and highlight the potential of NT-proBNP for remote monitoring via posted samples. TRIAL REGISTRATION: ClinicalTrials.gov registration: NCT05421949.