United European Gastroenterol J. 2021 May 7. doi: 10.1002/ueg2.12069. Online ahead of print.

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

Author information

• ¹Department of Biomedical Sciences, Humanitas University, Milan, Italy.
• ²Department of Gastroenterology and Inserm U1256, Nutrition - Genetics and Exposure to Environmental Risks, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France.
• ³Section of Gastroenterology, Hepatology and Nutrition, University of Chicago Department of Medicine, Chicago, Illinois, USA.
• ⁴IBD Outpatient Clinics, Catholic University or Paraná (PUCPR), Curitiba, Brazil.
• ⁵Department of Gastroenterology, Centro Hospitalar São João, Porto, Portugal.
• ⁶Medizinische Klinik m. S. Gastroenterologie, Infektiologie und Rheumatologie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
• ⁷Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
• ⁸Gastroenterology Section, Department of Internal Medicine, Centro de Educación Médica e Investigaciones Clínicas (CEMIC), Buenos Aires, Argentina.
• ⁹Imelda GI Clinical Research Center, Imelda General Hospital, Bonheiden, Belgium.
• ¹⁰Department of Gastroenterology, CHU Liège University Hospital, Liège, Belgium.
• ¹¹Gastroenterology Department, Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, Spain.
• ¹²Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain.
• ¹³Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
• ¹⁴NIHR Biomedical Research Centre, University of Birmingham and University Hospitals NHS Foundation Trust, Birmingham, UK.
• ¹⁵IBD Center, Humanitas Research Hospital, IRCCS, Milan, Italy.

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.