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Evaluation of a New NT-proBNP Immunoassay on an Automated Core Laboratory System.
Logan, Samantha; Di Meo, Ashley; Shapero, Stacey; Fabros, Anselmo; Taher, Jennifer; Kulasingam, Vathany.
Afiliación
  • Logan S; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
  • Di Meo A; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
  • Shapero S; Department of Clinical Biochemistry, Laboratory Medicine Program, University Health Network (UHN), Toronto, ON, Canada.
  • Fabros A; Department of Clinical Biochemistry, Laboratory Medicine Program, University Health Network (UHN), Toronto, ON, Canada.
  • Taher J; Department of Clinical Biochemistry, Laboratory Medicine Program, University Health Network (UHN), Toronto, ON, Canada.
  • Kulasingam V; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
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 (120.9 ng/L), medium (333.9 ng/L), and high (4767.4 ng/L) QC levels, respectively. The manufacturer's claimed LOQ of 8.3 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 250 ng/L or 6.02%. Subrange analysis (NT-proBNP <2000 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 26 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.
Asunto(s)

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

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
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