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Performance of the Abbott Architect Immuno-Chemiluminometric NT-proBNP Assay

Background: We evaluated the performance of the Abbott N-terminal pro-brain natriuretic peptide (NT-proBNP) assay against the Roche NT-proBNP immunoassay across two sites. Methods: Precision, linearity, and sensitivity studies were performed. A combined method of comparison and regression analysis w...

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Autores principales: Lau, Chin-Shern, Liang, Ya Li, Phua, Soon Kieng, Murtagh, Gillian, Hoefer, Imo E., Stokwielder, Ron H., Kosevich, Milica, Yen, Jennifer, Sickan, Jaganathan, Varounis, Christos, Aw, Tar-Choon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9140882/
https://www.ncbi.nlm.nih.gov/pubmed/35626327
http://dx.doi.org/10.3390/diagnostics12051172
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author Lau, Chin-Shern
Liang, Ya Li
Phua, Soon Kieng
Murtagh, Gillian
Hoefer, Imo E.
Stokwielder, Ron H.
Kosevich, Milica
Yen, Jennifer
Sickan, Jaganathan
Varounis, Christos
Aw, Tar-Choon
author_facet Lau, Chin-Shern
Liang, Ya Li
Phua, Soon Kieng
Murtagh, Gillian
Hoefer, Imo E.
Stokwielder, Ron H.
Kosevich, Milica
Yen, Jennifer
Sickan, Jaganathan
Varounis, Christos
Aw, Tar-Choon
author_sort Lau, Chin-Shern
collection PubMed
description Background: We evaluated the performance of the Abbott N-terminal pro-brain natriuretic peptide (NT-proBNP) assay against the Roche NT-proBNP immunoassay across two sites. Methods: Precision, linearity, and sensitivity studies were performed. A combined method of comparison and regression analysis was performed between the Roche and Abbott assays using samples from both sites (n = 494). To verify biotin interference, lyophilised biotin powder was reconstituted and spiked into serum samples at two medical decision levels (final concentration 500/4250 ng/mL) and compared to controls. NT-proBNP was also measured in anonymised leftover sera (n = 388) in a cardio-renal healthy population and stratified into three age bands—<50 (n = 145), 50–75 (n = 183) and >75 (n = 60). Results: Between-run precision (CV%) for NT-proBNP was 4.17/4.50 (139.5/142.0 pg/mL), 3.83/2.17 (521.6/506.3), and 4.60/2.51 (5053/4973), respectively. The assay was linear from 0.7–41,501 pg/mL. The limit of blank/quantitation was 1.2/7.9 pg/mL. The assay showed no interference from biotin up to 4250 ng/mL. Passing–Bablok regression analysis showed excellent agreement between the two assays (r = 0.999, 95% CI 0.999 to 0.999, p < 0.0001). The Roche assay had a slightly persistent, negative bias across different levels of NT-proBNP. ESC age cut-offs for diagnosing acute heart failure are applicable for the Abbott assay, with the median NT-proBNP of subjects < 50 years old at 43.0 pg/mL (range 4.9–456 pg/mL), 50–75 years old at 95.1 pg/mL (range 10.5–1079 pg/mL), and >75 years old at 173.1 pg/mL (range 23.2–1948 pg/mL). Conclusions: The Abbott Architect NT-proBNP assay has good performance that agrees with the manufacturer’s specifications. ESC/AHA recommended NT-proBNP age groups for acute heart failure diagnosis are applicable to this assay.
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spelling pubmed-91408822022-05-28 Performance of the Abbott Architect Immuno-Chemiluminometric NT-proBNP Assay Lau, Chin-Shern Liang, Ya Li Phua, Soon Kieng Murtagh, Gillian Hoefer, Imo E. Stokwielder, Ron H. Kosevich, Milica Yen, Jennifer Sickan, Jaganathan Varounis, Christos Aw, Tar-Choon Diagnostics (Basel) Article Background: We evaluated the performance of the Abbott N-terminal pro-brain natriuretic peptide (NT-proBNP) assay against the Roche NT-proBNP immunoassay across two sites. Methods: Precision, linearity, and sensitivity studies were performed. A combined method of comparison and regression analysis was performed between the Roche and Abbott assays using samples from both sites (n = 494). To verify biotin interference, lyophilised biotin powder was reconstituted and spiked into serum samples at two medical decision levels (final concentration 500/4250 ng/mL) and compared to controls. NT-proBNP was also measured in anonymised leftover sera (n = 388) in a cardio-renal healthy population and stratified into three age bands—<50 (n = 145), 50–75 (n = 183) and >75 (n = 60). Results: Between-run precision (CV%) for NT-proBNP was 4.17/4.50 (139.5/142.0 pg/mL), 3.83/2.17 (521.6/506.3), and 4.60/2.51 (5053/4973), respectively. The assay was linear from 0.7–41,501 pg/mL. The limit of blank/quantitation was 1.2/7.9 pg/mL. The assay showed no interference from biotin up to 4250 ng/mL. Passing–Bablok regression analysis showed excellent agreement between the two assays (r = 0.999, 95% CI 0.999 to 0.999, p < 0.0001). The Roche assay had a slightly persistent, negative bias across different levels of NT-proBNP. ESC age cut-offs for diagnosing acute heart failure are applicable for the Abbott assay, with the median NT-proBNP of subjects < 50 years old at 43.0 pg/mL (range 4.9–456 pg/mL), 50–75 years old at 95.1 pg/mL (range 10.5–1079 pg/mL), and >75 years old at 173.1 pg/mL (range 23.2–1948 pg/mL). Conclusions: The Abbott Architect NT-proBNP assay has good performance that agrees with the manufacturer’s specifications. ESC/AHA recommended NT-proBNP age groups for acute heart failure diagnosis are applicable to this assay. MDPI 2022-05-08 /pmc/articles/PMC9140882/ /pubmed/35626327 http://dx.doi.org/10.3390/diagnostics12051172 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Lau, Chin-Shern
Liang, Ya Li
Phua, Soon Kieng
Murtagh, Gillian
Hoefer, Imo E.
Stokwielder, Ron H.
Kosevich, Milica
Yen, Jennifer
Sickan, Jaganathan
Varounis, Christos
Aw, Tar-Choon
Performance of the Abbott Architect Immuno-Chemiluminometric NT-proBNP Assay
title Performance of the Abbott Architect Immuno-Chemiluminometric NT-proBNP Assay
title_full Performance of the Abbott Architect Immuno-Chemiluminometric NT-proBNP Assay
title_fullStr Performance of the Abbott Architect Immuno-Chemiluminometric NT-proBNP Assay
title_full_unstemmed Performance of the Abbott Architect Immuno-Chemiluminometric NT-proBNP Assay
title_short Performance of the Abbott Architect Immuno-Chemiluminometric NT-proBNP Assay
title_sort performance of the abbott architect immuno-chemiluminometric nt-probnp assay
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9140882/
https://www.ncbi.nlm.nih.gov/pubmed/35626327
http://dx.doi.org/10.3390/diagnostics12051172
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