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Article

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

by
Chin-Shern Lau
1,
Ya Li Liang
1,
Soon Kieng Phua
1,
Gillian Murtagh
2,
Imo E. Hoefer
3,
Ron H. Stokwielder
3,
Milica Kosevich
2,
Jennifer Yen
2,
Jaganathan Sickan
2,
Christos Varounis
2 and
Tar-Choon Aw
1,4,5,*
1
Department of Laboratory Medicine, Changi General Hospital, 2 SIMEI STREET 3, Singapore 529889, Singapore
2
Abbott Laboratories, Abbott Park, IL 60064, USA
3
Central Diagnostic Laboratory, University Medical Center, 3584 CX Utrecht, The Netherlands
4
Department of Medicine, National University of Singapore, Singapore 119077, Singapore
5
Academic Pathology Program, Duke-NUS Medical School, Singapore 169857, Singapore
*
Author to whom correspondence should be addressed.
Diagnostics 2022, 12(5), 1172; https://doi.org/10.3390/diagnostics12051172
Submission received: 29 March 2022 / Revised: 3 May 2022 / Accepted: 6 May 2022 / Published: 8 May 2022
(This article belongs to the Special Issue Cardiovascular Diseases: Diagnosis, Treatment, and Management—for the Up-to-Date Practitioner)
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Abstract

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.
Keywords: NT-proBNP; heart failure; immunoassay NT-proBNP; heart failure; immunoassay

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MDPI and ACS Style

Lau, C.-S.; Liang, Y.L.; Phua, S.K.; Murtagh, G.; Hoefer, I.E.; Stokwielder, R.H.; Kosevich, M.; Yen, J.; Sickan, J.; Varounis, C.; et al. Performance of the Abbott Architect Immuno-Chemiluminometric NT-proBNP Assay. Diagnostics 2022, 12, 1172. https://doi.org/10.3390/diagnostics12051172

AMA Style

Lau C-S, Liang YL, Phua SK, Murtagh G, Hoefer IE, Stokwielder RH, Kosevich M, Yen J, Sickan J, Varounis C, et al. Performance of the Abbott Architect Immuno-Chemiluminometric NT-proBNP Assay. Diagnostics. 2022; 12(5):1172. https://doi.org/10.3390/diagnostics12051172

Chicago/Turabian Style

Lau, Chin-Shern, Ya Li Liang, Soon Kieng Phua, Gillian Murtagh, Imo E. Hoefer, Ron H. Stokwielder, Milica Kosevich, Jennifer Yen, Jaganathan Sickan, Christos Varounis, and et al. 2022. "Performance of the Abbott Architect Immuno-Chemiluminometric NT-proBNP Assay" Diagnostics 12, no. 5: 1172. https://doi.org/10.3390/diagnostics12051172

APA Style

Lau, C.-S., Liang, Y. L., Phua, S. K., Murtagh, G., Hoefer, I. E., Stokwielder, R. H., Kosevich, M., Yen, J., Sickan, J., Varounis, C., & Aw, T.-C. (2022). Performance of the Abbott Architect Immuno-Chemiluminometric NT-proBNP Assay. Diagnostics, 12(5), 1172. https://doi.org/10.3390/diagnostics12051172

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