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Analytical evaluation of the novel Lumipulse G BRAHMS procalcitonin immunoassay

OBJECTIVES: This study was designed to evaluate the analytical performance of the novel Lumipulse G1200 BRAHMS procalcitonin (PCT) immunoassay. DESIGN AND METHODS: This analytical evaluation encompassed the calculation of the limit of blank (LOB), limit of detection (LOD), functional sensitivity, in...

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Autores principales: Ruzzenente, Orazio, Salvagno, Gian Luca, Gelati, Matteo, Lippi, Giuseppe
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5574867/
https://www.ncbi.nlm.nih.gov/pubmed/28856208
http://dx.doi.org/10.1016/j.plabm.2016.07.001
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author Ruzzenente, Orazio
Salvagno, Gian Luca
Gelati, Matteo
Lippi, Giuseppe
author_facet Ruzzenente, Orazio
Salvagno, Gian Luca
Gelati, Matteo
Lippi, Giuseppe
author_sort Ruzzenente, Orazio
collection PubMed
description OBJECTIVES: This study was designed to evaluate the analytical performance of the novel Lumipulse G1200 BRAHMS procalcitonin (PCT) immunoassay. DESIGN AND METHODS: This analytical evaluation encompassed the calculation of the limit of blank (LOB), limit of detection (LOD), functional sensitivity, intra- and inter-assay imprecision, confirmation of linearity and a comparison with the Vidas BRAHMS PCT assay. RESULTS: The LOB, LOD and functional sensitivity were 0.0010 ng/mL, 0.0016 ng/mL and 0.008 ng/mL, respectively. The total analytical imprecision was found to be 2.1% and the linearity was excellent (r=1.00) in the range of concentrations between 0.006–75.5 ng/mL. The correlation coefficient with Vidas BRAHMS PCT was 0.995 and the equation of the Passing and Bablok regression analysis was [Lumipulse G BRAHMS PCT]=0.76×[Vidas BRAHMS PCT]+0.04. The mean overall bias of Lumipulse G BRAHMS PCT versus Vidas BRAHMS PCT was −3.03 ng/mL (95% confidence interval [CI]: −4.32 to −1.74 ng/mL), whereas the mean bias in samples with PCT concentration between 0–10 ng/mL was −0.49 ng/mL (95% CI: −0.77 to −0.24 ng/mL). The diagnostic agreement was 100% at 0.5 ng/mL, 97% at 2.0 ng/mL and 95% at 10 ng/mL, respectively. CONCLUSIONS: These results attest that Lumipulse G BRAHMS PCT exhibits excellent analytical performance, among the best of the methods currently available on the diagnostic market. However, the significant bias compared to the Vidas BRAHMS PCT suggests that the methods cannot be used interchangeably.
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spelling pubmed-55748672017-08-30 Analytical evaluation of the novel Lumipulse G BRAHMS procalcitonin immunoassay Ruzzenente, Orazio Salvagno, Gian Luca Gelati, Matteo Lippi, Giuseppe Pract Lab Med Article OBJECTIVES: This study was designed to evaluate the analytical performance of the novel Lumipulse G1200 BRAHMS procalcitonin (PCT) immunoassay. DESIGN AND METHODS: This analytical evaluation encompassed the calculation of the limit of blank (LOB), limit of detection (LOD), functional sensitivity, intra- and inter-assay imprecision, confirmation of linearity and a comparison with the Vidas BRAHMS PCT assay. RESULTS: The LOB, LOD and functional sensitivity were 0.0010 ng/mL, 0.0016 ng/mL and 0.008 ng/mL, respectively. The total analytical imprecision was found to be 2.1% and the linearity was excellent (r=1.00) in the range of concentrations between 0.006–75.5 ng/mL. The correlation coefficient with Vidas BRAHMS PCT was 0.995 and the equation of the Passing and Bablok regression analysis was [Lumipulse G BRAHMS PCT]=0.76×[Vidas BRAHMS PCT]+0.04. The mean overall bias of Lumipulse G BRAHMS PCT versus Vidas BRAHMS PCT was −3.03 ng/mL (95% confidence interval [CI]: −4.32 to −1.74 ng/mL), whereas the mean bias in samples with PCT concentration between 0–10 ng/mL was −0.49 ng/mL (95% CI: −0.77 to −0.24 ng/mL). The diagnostic agreement was 100% at 0.5 ng/mL, 97% at 2.0 ng/mL and 95% at 10 ng/mL, respectively. CONCLUSIONS: These results attest that Lumipulse G BRAHMS PCT exhibits excellent analytical performance, among the best of the methods currently available on the diagnostic market. However, the significant bias compared to the Vidas BRAHMS PCT suggests that the methods cannot be used interchangeably. Elsevier 2016-07-16 /pmc/articles/PMC5574867/ /pubmed/28856208 http://dx.doi.org/10.1016/j.plabm.2016.07.001 Text en © 2016 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Ruzzenente, Orazio
Salvagno, Gian Luca
Gelati, Matteo
Lippi, Giuseppe
Analytical evaluation of the novel Lumipulse G BRAHMS procalcitonin immunoassay
title Analytical evaluation of the novel Lumipulse G BRAHMS procalcitonin immunoassay
title_full Analytical evaluation of the novel Lumipulse G BRAHMS procalcitonin immunoassay
title_fullStr Analytical evaluation of the novel Lumipulse G BRAHMS procalcitonin immunoassay
title_full_unstemmed Analytical evaluation of the novel Lumipulse G BRAHMS procalcitonin immunoassay
title_short Analytical evaluation of the novel Lumipulse G BRAHMS procalcitonin immunoassay
title_sort analytical evaluation of the novel lumipulse g brahms procalcitonin immunoassay
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5574867/
https://www.ncbi.nlm.nih.gov/pubmed/28856208
http://dx.doi.org/10.1016/j.plabm.2016.07.001
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