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. 2021 May;9(4):451-460.
doi: 10.1002/ueg2.12069. Epub 2021 May 7.

International consensus on methodological issues in standardization of fecal calprotectin measurement in inflammatory bowel diseases

Ferdinando D'Amico  1   2 , David T Rubin  3 , Paulo Gustavo Kotze  4 , Fernando Magro  5 , Britta Siegmund  6 , Taku Kobayashi  7 , Pablo A Olivera  8 , Peter Bossuyt  9 , Lieven Pouillon  9 , Edouard Louis  10 , Eugeni Domènech  11   12   13 , Subrata Ghosh  14 , Silvio Danese  1   15 , Laurent Peyrin-Biroulet  2
Affiliations

International consensus on methodological issues in standardization of fecal calprotectin measurement in inflammatory bowel diseases

Ferdinando D'Amico et al. United European Gastroenterol J. 2021 May.

Abstract

Background: Fecal calprotectin (FC) is a non-invasive marker of gut inflammation which is frequently used to guide therapeutic decisions in patients with inflammatory bowel diseases (IBD). Each step of FC measurement can influence the results, leading to misinterpretations and potentially impacting the management of IBD patients. To date, there is high heterogeneity between FC measurements and no current method is universally accepted as a standard.

Aims: Our aim was to provide clear position statementsabout the pre-analytical and the analytical phases of FC measurement to homogenize FC levels and to minimize variability and risk of misinterpretation through aninternational consensus.

Materials & methods: Fourteen physicians with expertise in the field of IBD and FC from 11 countries attended a virtual international consensus meeting on July 17th, 2020. A systematic literature was conducted and the literature evidence was shared and discussedamong the participants. Statements were formulated, discussed, and voted. Statements were considered approved if all participants agreed.

Results: Nine statements were formulated and approved. Based on the available evidence, quantitative tests should be preferred for measuring FC. Furthermore, FC measurement, if possible, should always be performed with the same method and factors influencing FC levels should be taken into account when interpreting the results.

Discussion: FC has an increasingly important role in the management of patients with IBD. However, large multicenter studies should be conducted to define the reproducibility and to confirm the diagnostic accuracy of the available FC tests.

Conclusion: FC concentrations guide clinicians' treatment decisions. Our statements have a relevant impact in daily practice and could be applied in clinical trials to standardize FC measurement.

Keywords: fecal calprotectin; inflammatory bowel disease; measurement; standardization.

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Conflict of interest statement

Ferdinando D’Amico declares no conflict of interest. David T. Rubin has received grant support from Takeda; and has served as a consultant for Abbvie, Abgenomics, Allergan Inc., Biomica, Boehringer Ingelheim Ltd., Bristol‐Myers Squibb, Celgene Corp/Syneos, Check‐cap, Dizal Pharmaceuticals, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, GlaxoSmithKline Services, Ichnos Sciences S.A., InDex Pharmaceuticals, Janssen Pharmaceuticals, Lilly, Narrow River Mgmt, Pfizer, Prometheus Laboratories, Reistone, Shire, Takeda, and Techlab Inc. Fernando Magro has served as a speaker and received honoraria from Merck Sharp & Dohme, Abbvie, Vifor, Falk, Laboratorios Vitoria, Ferring, Hospira, and Biogen. Britta Siegmund has served as Consultant for Abbvie, Boehringer, Celgene, Falk, Janssen, Lilly, Pfizer, Prometheus, Takeda and received speaker's fees from Abbvie, CED Service GmbH, Falk, Ferring, Janssen, Novartis, Takeda (BS served as representative of theCharité). Subrata Ghosh declares consulting fees from Pfizer, Janssen, AbbVie, Takeda, Bristol‐Myers Squibb, Receptos, Celgene, Gilead, Eli Lilly and Boehringer Ingelheim and speaker fees from AbbVie, Janssen, Takeda, Ferring, Shield, and Falk Pharma; outside of the submitted work. Taku Kobayashi has served as a speaker, a consultant or an advisory board member for AbbVie, Ajinomoto Pharma, Asahi Kasei Medical, Astellas, Alfresa Pharma, Celltrion, Covidien, EA Pharma, Eisai, Eli Lilly, Ferring Pharmaceuticals, Gilead Sciences, Janssen, JIMRO, Kyorin Pharmaceutical, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Nippon Kayaku, Pfizer, Takeda Pharmaceutical, Thermo Scientific, Zeria Pharmaceutical, and received research funding from AbbVie, Alfresa Pharma, Asahi Kasei Medical, EA Pharma, Kyorin Pharmaceutical, Mochida Pharmaceutical, Nippon Kayaku, Otsuka Holdings, Sekisui Medical, Thermo Fisher Scientific, Zeria Pharmaceutical. Paulo Gustavo Kotze reports personal fees from Abbvie, Janssen, Pfizer and Takeda; research grants from Pfizer and Takeda. Pablo A. Olivera received consulting fees from Abbvie, Takeda, and Janssen and lecture fees from Takeda and Janssen. Peter Bossuyt received has received financial support for research from AbbVie, Mundipharma, Pfizer, Janssen, Amgen, and Mylan; lecture fees from AbbVie, Takeda, Pfizer, and Janssen; advisory board fees from Abbvie, Takeda, Hospira, Janssen, Celltrion, BMS, Roche, Arena, MSD, Mundipharma, Roche, Pfizer, Sandoz, and Pentax. Lieven Pouillon received advisory board fees from Janssen and Takeda; presentation fees from Abbvie and Ferring; and personal fees from Abbvie, Ferring, Norgine, and Takeda. Edouard Louis reports grants from European Commission for BIOCYCLE Research Programme; grants and personal fees from Abbvie, Takeda, Pfizer and Janssen and personal fees from MSD, Ferring, Falk, and Celgene. Eugeni Domènech has served as a speaker and has received research and educational funding and advisory fees from MSD, AbbVie, Takeda, Kern Pharma, Pfizer, Janssen, Celgene, Adacyte Therapeutics, Otsuka Pharmaceuticals, Ferring, Shire Pharmaceuticals, Tillots, Thermofisher, Grifols, and Gebro. Silvio Danese has served as a speaker, consultant, and advisory board member for Schering‐Plough, AbbVie, Actelion, Alphawasserman, AstraZeneca, Cellerix, Cosmo Pharmaceuticals, Ferring, Genentech, Grunenthal, Johnson and Johnson, Millenium Takeda, MSD, Nikkiso Europe GmbH, Novo Nordisk, Nycomed, Pfizer, Pharmacosmos, UCB Pharma and Vifor. Laurent Peyrin‐Biroulet has served as a speaker, consultant and advisory board member for Merck, Abbvie, Janssen, Genentech, Mitsubishi, Ferring, Norgine, Tillots, Vifor, Hospira/Pfizer, Celltrion, Takeda, Biogaran, Boerhinger‐Ingelheim, Lilly, HAC‐ Pharma, Index Pharmaceuticals, Amgen, Sandoz, For‐ward Pharma GmbH, Celgene, Biogen, Lycera, Samsung Bioepis, Theravance.

Figures

FIGURE 1
FIGURE 1
Research gaps that could be filled with standardization of fecal calprotectin measurement
See this image and copyright information in PMC

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