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Evaluation of a fluorescent immunochromatography test for fecal calprotectin

BACKGROUND: Fecal calprotectin (FC) is widely used to discriminate between patients with inflammatory diseases such as inflammatory bowel disease (IBD) and functional diseases such as irritable bowel syndrome (IBS). ELISA is a time‐consuming method for the measurement of FC, whereas a fluorescent im...

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Autores principales: Li, Runqing, Zhao, Xiuying, Dong, Jingxiao, Zhu, Dong, Wang, Tengjiao, Yang, Song, Zhao, Zhipeng, Xiao, Nan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7031577/
https://www.ncbi.nlm.nih.gov/pubmed/31587371
http://dx.doi.org/10.1002/jcla.23059
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author Li, Runqing
Zhao, Xiuying
Dong, Jingxiao
Zhu, Dong
Wang, Tengjiao
Yang, Song
Zhao, Zhipeng
Xiao, Nan
author_facet Li, Runqing
Zhao, Xiuying
Dong, Jingxiao
Zhu, Dong
Wang, Tengjiao
Yang, Song
Zhao, Zhipeng
Xiao, Nan
author_sort Li, Runqing
collection PubMed
description BACKGROUND: Fecal calprotectin (FC) is widely used to discriminate between patients with inflammatory diseases such as inflammatory bowel disease (IBD) and functional diseases such as irritable bowel syndrome (IBS). ELISA is a time‐consuming method for the measurement of FC, whereas a fluorescent immunochromatography test can obtain results in around 30 minutes and thus enables a rapid response to clinical decision. METHODS: Two methods, the Proglead(®) calprotectin (FC Proglead) and the BÜHLMANN fCAL(®) ELISA (FC BÜHLMANN), were used to quantitatively examine FC in 111 stool samples. The comparison and bias estimation of both assays were assessed using CLSI EP09c protocol. RESULTS: The two methods were highly correlated (rho = .96). Deming regression was employed to calculate the regression equation, with a slope of 1.01 and an intercept of −4.98 μg/g. The estimated median bias (FC Proglead − FC BÜHLMANN) was −4.19 μg/g with the 95% limits of agreement (−55.59 to 47.21 μg/g), and the estimated median percent bias was −8.71% with the 95% limits of agreement (−50.31% to 32.90%). There was 4.50% (5/111) of values outside the 95% limits of agreement. Percent biases at the FC cutoff values of 50 and 200 μg/g between both methods evaluated by Deming regression were 8.96% and 1.49%, respectively. The biases were all less than the acceptable standard (10%). And, 99.10% of FC results were in agreement between both methods (kappa = .99, P < .001). CONCLUSIONS: FC Proglead may be used as a suitable alternative to FC BÜHLMANN for the disease activity assessment for patients with IBD, considering its convenience and shorter turnaround time.
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spelling pubmed-70315772020-02-27 Evaluation of a fluorescent immunochromatography test for fecal calprotectin Li, Runqing Zhao, Xiuying Dong, Jingxiao Zhu, Dong Wang, Tengjiao Yang, Song Zhao, Zhipeng Xiao, Nan J Clin Lab Anal Research Articles BACKGROUND: Fecal calprotectin (FC) is widely used to discriminate between patients with inflammatory diseases such as inflammatory bowel disease (IBD) and functional diseases such as irritable bowel syndrome (IBS). ELISA is a time‐consuming method for the measurement of FC, whereas a fluorescent immunochromatography test can obtain results in around 30 minutes and thus enables a rapid response to clinical decision. METHODS: Two methods, the Proglead(®) calprotectin (FC Proglead) and the BÜHLMANN fCAL(®) ELISA (FC BÜHLMANN), were used to quantitatively examine FC in 111 stool samples. The comparison and bias estimation of both assays were assessed using CLSI EP09c protocol. RESULTS: The two methods were highly correlated (rho = .96). Deming regression was employed to calculate the regression equation, with a slope of 1.01 and an intercept of −4.98 μg/g. The estimated median bias (FC Proglead − FC BÜHLMANN) was −4.19 μg/g with the 95% limits of agreement (−55.59 to 47.21 μg/g), and the estimated median percent bias was −8.71% with the 95% limits of agreement (−50.31% to 32.90%). There was 4.50% (5/111) of values outside the 95% limits of agreement. Percent biases at the FC cutoff values of 50 and 200 μg/g between both methods evaluated by Deming regression were 8.96% and 1.49%, respectively. The biases were all less than the acceptable standard (10%). And, 99.10% of FC results were in agreement between both methods (kappa = .99, P < .001). CONCLUSIONS: FC Proglead may be used as a suitable alternative to FC BÜHLMANN for the disease activity assessment for patients with IBD, considering its convenience and shorter turnaround time. John Wiley and Sons Inc. 2019-10-06 /pmc/articles/PMC7031577/ /pubmed/31587371 http://dx.doi.org/10.1002/jcla.23059 Text en © 2019 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals, Inc. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Research Articles
Li, Runqing
Zhao, Xiuying
Dong, Jingxiao
Zhu, Dong
Wang, Tengjiao
Yang, Song
Zhao, Zhipeng
Xiao, Nan
Evaluation of a fluorescent immunochromatography test for fecal calprotectin
title Evaluation of a fluorescent immunochromatography test for fecal calprotectin
title_full Evaluation of a fluorescent immunochromatography test for fecal calprotectin
title_fullStr Evaluation of a fluorescent immunochromatography test for fecal calprotectin
title_full_unstemmed Evaluation of a fluorescent immunochromatography test for fecal calprotectin
title_short Evaluation of a fluorescent immunochromatography test for fecal calprotectin
title_sort evaluation of a fluorescent immunochromatography test for fecal calprotectin
topic Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7031577/
https://www.ncbi.nlm.nih.gov/pubmed/31587371
http://dx.doi.org/10.1002/jcla.23059
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