Evaluation of a New NT-proBNP Immunoassay on an Automated Core Laboratory System.
J Appl Lab Med
; 9(3): 579-585, 2024 May 02.
Article
en En
| MEDLINE
| ID: mdl-38170842
ABSTRACT
BACKGROUND:
Heart failure remains a major cause of morbidity and mortality despite improvements in treatment. This study aimed to evaluate the Alere N-terminal pro B-type natriuretic peptide (NT-proBNP) immunoassay on the Abbott Alinity i platform.METHODS:
The analytical performance including precision, linearity, limit of quantitation (LOQ), carryover, dilution-recovery, and stability was evaluated. A method comparison between the Abbott Alere NT-proBNP assay and Roche Elecsys proBNP II assay was performed using 70 residual plasma samples.RESULTS:
Total imprecision was 4.1%, 3.5%, and 2.3% for low (120.9â ng/L), medium (333.9â ng/L), and high (4767.4â ng/L) QC levels, respectively. The manufacturer's claimed LOQ of 8.3â ng/L was verified. Method comparison between the Alere NT-proBNP assay and the Elecsys proBNP II assay showed good agreement between assays with an R value of 0.998, a slope of 1.05 (95% CI, 1.03-1.06), and an intercept of 45.81 (95% CI, -46.6.84 to 138.22). The Bland-Altman plot showed an absolute bias of 250â ng/L or 6.02%. Subrange analysis (NT-proBNP <2000â ng/L) showed good agreement with an R value of 0.998, a slope of 1.04 (95% CI, 1.02-1.06), and an intercept of -4.83 (95% CI, -26.95 to 17.28), with a mean bias of 26â ng/L or 3.2%. The stability of NT-proBNP was also verified in lithium heparin plasma samples stored at 4°C over a 7-day period. Hemolysis and lipemia interference thresholds were verified, but icterus impacted NT-proBNP recovery by >20% at low analyte concentrations.CONCLUSIONS:
The Alere NT-proBNP assay demonstrated acceptable analytical performance and very good clinical concordance with the Elecsys proBNP II assay.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Fragmentos de Péptidos
/
Péptido Natriurético Encefálico
Límite:
Humans
Idioma:
En
Revista:
J Appl Lab Med
Año:
2024
Tipo del documento:
Article
País de afiliación:
Canadá