Analytical and clinical evaluation of DiaSorin Liaison® Calprotectin fecal assay adapted for serum samples

Background Calprotectin is a calcium-binding protein that can be measured in serum, plasma, and feces. Increased serum and plasma calprotectin concentrations have been found in chronic inflammatory rheumatic disorders. An analytical and clinical evaluation of the DiaSorin Liaison (R) fecal Calprotec...

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Autores: Macías Muñoz, Laura, Frade Sosa, Beatriz, Iniciarte Mundo, José, Hidalgo, Susana, Morlà, Rosa Maria, Gallegos, Yadira, Sanmartí Sala, Raimon, Auge, Josep Maria
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/201463
Acceso en línea:https://hdl.handle.net/2445/201463
Access Level:acceso abierto
Palabra clave:Artritis reumatoide
Marcadors bioquímics
Assaigs clínics
Rheumatoid arthritis
Biochemical markers
Clinical trials
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spelling Analytical and clinical evaluation of DiaSorin Liaison® Calprotectin fecal assay adapted for serum samplesMacías Muñoz, LauraFrade Sosa, BeatrizIniciarte Mundo, JoséHidalgo, SusanaMorlà, Rosa MariaGallegos, YadiraSanmartí Sala, RaimonAuge, Josep MariaArtritis reumatoideMarcadors bioquímicsAssaigs clínicsRheumatoid arthritisBiochemical markersClinical trialsBackground Calprotectin is a calcium-binding protein that can be measured in serum, plasma, and feces. Increased serum and plasma calprotectin concentrations have been found in chronic inflammatory rheumatic disorders. An analytical and clinical evaluation of the DiaSorin Liaison (R) fecal Calprotectin assay using LIAISON (R) XL was performed. Methods The protocol included an analytical and clinical evaluation in which imprecision, the linearity of dilution, differences between serum and plasma samples and method comparison with CalproLab (TM) ELISA kit were assessed. Serum calprotectin concentrations in active (n = 26) and remission (n = 23) rheumatoid arthritis (RA) patients were compared. Results The intra-day and inter-day analytical imprecision CVs ranged from 2.9% to 4.0% and 2.7% to 10.4%, respectively. Correlation between measured and expected values was high (R > 0.99), indicating good linearity. The Wilcoxon signed-rank test showed that serum and plasma matched samples presented statistically significant differences (p < 0.001) being the highest concentrations of calprotectin observed in serum samples. Deming regression equation was as follows: Diasorin calprotectin (mu g/ml) = -0.32 (95% CI: -0.65 - -0.05) +1.58 (95% CI: 1.42-1.79).* Calprolab calprotectin (mu g/ml). Significantly higher serum calprotectin levels were found in RA patients with active disease when compared to patients with low disease activity or in clinical remission (mean +/- SD) [(3.35 mu g/ml +/- 1.55) vs. (1.63 mu g/ml +/- 0.52), p < 0.001] and these levels correlated well with all disease activity indices. Conclusions The DiaSorin Liaison (R) fecal Calprotectin assay adapted for serum samples showed adequate technical performances and the clinical performances were similar to other assays.Wiley2022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/201463Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1002/jcla.24258Journal of Clinical Laboratory Analysis, 2022, vol. 36, num. 3, p. e24258https://doi.org/10.1002/jcla.24258cc by-nc-nd (c) Macías Muñoz, Laura et al., 2022http://creativecommons.org/licenses/by-nc-nd/3.0/es/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/2014632026-05-27T06:46:51Z
dc.title.none.fl_str_mv Analytical and clinical evaluation of DiaSorin Liaison® Calprotectin fecal assay adapted for serum samples
title Analytical and clinical evaluation of DiaSorin Liaison® Calprotectin fecal assay adapted for serum samples
spellingShingle Analytical and clinical evaluation of DiaSorin Liaison® Calprotectin fecal assay adapted for serum samples
Macías Muñoz, Laura
Artritis reumatoide
Marcadors bioquímics
Assaigs clínics
Rheumatoid arthritis
Biochemical markers
Clinical trials
title_short Analytical and clinical evaluation of DiaSorin Liaison® Calprotectin fecal assay adapted for serum samples
title_full Analytical and clinical evaluation of DiaSorin Liaison® Calprotectin fecal assay adapted for serum samples
title_fullStr Analytical and clinical evaluation of DiaSorin Liaison® Calprotectin fecal assay adapted for serum samples
title_full_unstemmed Analytical and clinical evaluation of DiaSorin Liaison® Calprotectin fecal assay adapted for serum samples
title_sort Analytical and clinical evaluation of DiaSorin Liaison® Calprotectin fecal assay adapted for serum samples
dc.creator.none.fl_str_mv Macías Muñoz, Laura
Frade Sosa, Beatriz
Iniciarte Mundo, José
Hidalgo, Susana
Morlà, Rosa Maria
Gallegos, Yadira
Sanmartí Sala, Raimon
Auge, Josep Maria
author Macías Muñoz, Laura
author_facet Macías Muñoz, Laura
Frade Sosa, Beatriz
Iniciarte Mundo, José
Hidalgo, Susana
Morlà, Rosa Maria
Gallegos, Yadira
Sanmartí Sala, Raimon
Auge, Josep Maria
author_role author
author2 Frade Sosa, Beatriz
Iniciarte Mundo, José
Hidalgo, Susana
Morlà, Rosa Maria
Gallegos, Yadira
Sanmartí Sala, Raimon
Auge, Josep Maria
author2_role author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Artritis reumatoide
Marcadors bioquímics
Assaigs clínics
Rheumatoid arthritis
Biochemical markers
Clinical trials
topic Artritis reumatoide
Marcadors bioquímics
Assaigs clínics
Rheumatoid arthritis
Biochemical markers
Clinical trials
description Background Calprotectin is a calcium-binding protein that can be measured in serum, plasma, and feces. Increased serum and plasma calprotectin concentrations have been found in chronic inflammatory rheumatic disorders. An analytical and clinical evaluation of the DiaSorin Liaison (R) fecal Calprotectin assay using LIAISON (R) XL was performed. Methods The protocol included an analytical and clinical evaluation in which imprecision, the linearity of dilution, differences between serum and plasma samples and method comparison with CalproLab (TM) ELISA kit were assessed. Serum calprotectin concentrations in active (n = 26) and remission (n = 23) rheumatoid arthritis (RA) patients were compared. Results The intra-day and inter-day analytical imprecision CVs ranged from 2.9% to 4.0% and 2.7% to 10.4%, respectively. Correlation between measured and expected values was high (R > 0.99), indicating good linearity. The Wilcoxon signed-rank test showed that serum and plasma matched samples presented statistically significant differences (p < 0.001) being the highest concentrations of calprotectin observed in serum samples. Deming regression equation was as follows: Diasorin calprotectin (mu g/ml) = -0.32 (95% CI: -0.65 - -0.05) +1.58 (95% CI: 1.42-1.79).* Calprolab calprotectin (mu g/ml). Significantly higher serum calprotectin levels were found in RA patients with active disease when compared to patients with low disease activity or in clinical remission (mean +/- SD) [(3.35 mu g/ml +/- 1.55) vs. (1.63 mu g/ml +/- 0.52), p < 0.001] and these levels correlated well with all disease activity indices. Conclusions The DiaSorin Liaison (R) fecal Calprotectin assay adapted for serum samples showed adequate technical performances and the clinical performances were similar to other assays.
publishDate 2022
dc.date.none.fl_str_mv 2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/201463
url https://hdl.handle.net/2445/201463
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1002/jcla.24258
Journal of Clinical Laboratory Analysis, 2022, vol. 36, num. 3, p. e24258
https://doi.org/10.1002/jcla.24258
dc.rights.none.fl_str_mv cc by-nc-nd (c) Macías Muñoz, Laura et al., 2022
http://creativecommons.org/licenses/by-nc-nd/3.0/es/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc by-nc-nd (c) Macías Muñoz, Laura et al., 2022
http://creativecommons.org/licenses/by-nc-nd/3.0/es/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Wiley
publisher.none.fl_str_mv Wiley
dc.source.none.fl_str_mv Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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