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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...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2016
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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. |
format | Online Article Text |
id | pubmed-5574867 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
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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