Validation of a Novel Point-of-Care Testing Device Designed for Assessment of NT-pro BNP

Abstract

Aim: Our main objective was to compare Point-Of-Care Technology (POCT) to central laboratory immunochemistry testing, to assess N-terminal pro B-type Natriuretic Peptide (NT-proBNP) in ambulatory patients. A second objective was to use POCT to analyze NT-proBNP in a cohort of healthy blood donors to define reference values. Methods: Blood samples were obtained from 102 outpatients and 133 blood donors, respectively. Samples analyzed using a point-of-care instrument [NT-proBNPLumiraDx (LumiraDx, Solna, Sweden)] were compared to a commercial electrochemiluminescence immunoassay method [(NT-proBNPRoche) on the Cobas Pro analyzer (Roche Diagnostics, Mannheim, Germany)]. The study was ethically approved (01–367) and complied with the Declaration of Helsinki. Values are given as Median and Interquartile Range (IQR). Results: There was a distinct correlation between the two assays for assessing the circulating levels of NT-proBNP in outpatients (R² = 0.9546). NT-proBNPLumiraDx ranged between 50–3966 ng/L [Median: 276 (IQR: 679)] whereas NT-proBNPRoche ranged between 50–3820 ng/L; (Median: 268 (IQR: 628)]. NT-proBNPLumiraDx was 3% higher than NT-proBNPRoche (p<0.05). NT-proBNPLumiraDx levels were not affected by age in our cohort of blood donors. Conclusion: In cases where short turn-around-times for assessment of NT-proBNP are desirable, the LumiraDx instrument can safely be used as an analytical option.