Academic Journal
Analytical and Clinical Performance Evaluation of a Novel NT-proBNP Assay with De Novo Antibodies across Different Population Groups.
| Τίτλος: | Analytical and Clinical Performance Evaluation of a Novel NT-proBNP Assay with De Novo Antibodies across Different Population Groups. |
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| Συγγραφείς: | Dupuy AM; Laboratoire de Biochimie et Hormonologie, CHU Montpellier, Univ Montpellier 1, Montpellier, France., Mondesert E; Laboratoire de Biochimie et Hormonologie, CHU Montpellier, Univ Montpellier 1, Montpellier, France.; PhyMedExp, Université de Montpellier, INSERM, CNRS, Laboratoire de Biochimie et Hormonologie, CHU de Montpellier, Montpellier, France., Margueritte L; Laboratoire de Biochimie et Hormonologie, CHU Montpellier, Univ Montpellier 1, Montpellier, France., Charif D; Laboratoire de Biochimie et Hormonologie, CHU Montpellier, Univ Montpellier 1, Montpellier, France., Morena M; Laboratoire de Biochimie et Hormonologie, CHU Montpellier, Univ Montpellier 1, Montpellier, France.; PhyMedExp, Université de Montpellier, INSERM, CNRS, Laboratoire de Biochimie et Hormonologie, CHU de Montpellier, Montpellier, France., Bargnoux AS; Laboratoire de Biochimie et Hormonologie, CHU Montpellier, Univ Montpellier 1, Montpellier, France.; PhyMedExp, Université de Montpellier, INSERM, CNRS, Laboratoire de Biochimie et Hormonologie, CHU de Montpellier, Montpellier, France., Roubille F; PhyMedExp, Université de Montpellier, INSERM, CNRS, Laboratoire de Biochimie et Hormonologie, CHU de Montpellier, Montpellier, France.; Département de Cardiologie, Univ Montpellier 1, Montpellier, France., Cristol JP; Laboratoire de Biochimie et Hormonologie, CHU Montpellier, Univ Montpellier 1, Montpellier, France.; PhyMedExp, Université de Montpellier, INSERM, CNRS, Laboratoire de Biochimie et Hormonologie, CHU de Montpellier, Montpellier, France. |
| Πηγή: | The journal of applied laboratory medicine [J Appl Lab Med] 2026 Jul 01; Vol. 11 (4), pp. 709-722. |
| Τύπος έκδοσης: | Journal Article; Comparative Study; Evaluation Study |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Oxford University Press Country of Publication: England NLM ID: 101693884 Publication Model: Print Cited Medium: Print ISSN: 2576-9456 (Print) Linking ISSN: 24757241 NLM ISO Abbreviation: J Appl Lab Med Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2020- : Oxford : Oxford University Press Original Publication: [Washington, DC] : American Association for Clinical Chemistry, [2016]-[2019] |
| Ιατρικοί όροι (MeSH): | Natriuretic Peptide, Brain*/blood , Natriuretic Peptide, Brain*/immunology , Peptide Fragments*/blood , Peptide Fragments*/immunology , Heart Failure*/blood , Heart Failure*/diagnosis , Renal Insufficiency, Chronic*/blood , Renal Insufficiency, Chronic*/diagnosis , Antibodies*/immunology, Immunoassay/methods ; Biomarkers/blood ; Humans ; Female ; Male ; Middle Aged ; Aged ; Adult ; Aged, 80 and over ; Reproducibility of Results |
| Περίληψη: | Background: A new N-terminal pro-B-type natriuretic peptide (NT-proBNP) immunoassay using de novo antibodies was developed on a DxI9000© analyzer from Beckman. The aim of this study was to assess its analytical performance, and a comparison with the Elecsys-proBNPII assay from Roche was also performed. NT-proBNP values in healthy adults based on sex and age were established, and clinical performance in the diagnosis of chronic heart failure (CHF), acute heart failure (AHF), aging, and chronic kidney disease (CKD) populations was evaluated. Methods: Analytical performance of the Access NT-proBNP assay was evaluated. A method comparison was performed using 200 fresh plasma samples as well as with all the patient samples included in the study (n = 531). The distribution of Access NT-proBNP levels in healthy subjects, patients with CHF or AHF, and patients with CKD was reported. Results: The total imprecision for NT-proBNP controls was 3.17% and 4.73%, and 3.70% and 10.45% in a plasma pool. The limit of blank and limit of detection were lower than those reported by the manufacturer. Correlation studies showed a good correlation between NT-proBNP measurements using the Access NT-proBNP assay and Roche analyzer.In a healthy population, the NT-proBNP concentrations increased across the age groups and significantly varied in healthy adult men and women throughout the years. In the different pathological situations studied, our results clearly demonstrated that the new NT-proBNP assay from Beckman meets European Society of Cardiology requirements for diagnostic approaches and monitoring of patients suspected of having chronic heart failure. Conclusion: The Access NT-proBNP assay showed acceptable analytical and diagnostic performance in heart failure. In cases of renal failure, our study encourages cautious interpretation of results. (© The Author(s) 2026. Published by Oxford University Press on behalf of Association for Diagnostics & Laboratory Medicine.) |
| Grant Information: | Beckman-Coulter, Inc. |
| Substance Nomenclature: | 114471-18-0 (Natriuretic Peptide, Brain) 0 (pro-brain natriuretic peptide (1-76)) 0 (Peptide Fragments) 0 (Biomarkers) 0 (Antibodies) |
| Entry Date(s): | Date Created: 20260429 Date Completed: 20260701 Latest Revision: 20260701 |
| Update Code: | 20260702 |
| DOI: | 10.1093/jalm/jfag049 |
| PMID: | 42053996 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 2576-9456 |
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| DOI: | 10.1093/jalm/jfag049 |