*Full list of contributors:
Cezmi A. Akdis 13, Alberto Alvarez-Perea14, Montserrat Alvaro Lozano 15, Riccardo Asero16, Barbara Ballmer-Weber17,18, Domingo Barber19,20, Simona Barni21, Giovanni Battista Pajno22, Kirsten Beyer23, Carsten Bindslev-Jensen24, Helen Brough25, 26, 27, Betul Buyuktiryaki28, Lucila Camargo Lopes de Oliveira29, Antonella Cianferoni30, R Sharon Chinthrajah31,32, Stefano Del Giacco33, Audrey DunnGalvin34,35,36, Bernadette Eberlein37, Motohiro Ebisawa38, Philippe Eigenmann39, Thomas Eiwegger40,41,42, Margaretha Faber43, Montserrat Fernandez-Rivas44, Mary Feeney26,27, Helen Fisher27, Mattia Giovannini45, Susanne Halken46, Karin Hoffmann-Sommergruber47, Hannah Jaumdally27, Christina J Jones48, Rebecca Knibb49, Edward Knol50, George N Konstantinou51, Marta Krawiec26,27, Susanne Lau52, Lina Mayorga53, M. Andreina Marques-Mejias26,27, Rosan Meyer54, Beatriz Moya55, Charlotte G Mortz24, Antonella Muraro56, Kari Nadeau31,32, Caroline Nilsson57,58, Liam O’Mahony59, Nikolaos G. Papadopoulos60,61, Kirsten Perrett62, Alexandre Piletta-Zanin39, Marcia Podestà63, Lars K. Poulsen64, Cristian Ricci1, Graham Roberts65,66, Hugh Sampson67, Sylwia Smolińska68, Jürgen Schwarze69, Eva Untersmayr70, Ronald Van Ree71, Carina Venter72, Brian P. Vickery73, Berber Vlieg-Boerstra74
13 Swiss Institute of Allergy and Asthma Research
14 Hospital General Universitario Gregorio Marañón, Madrid, Spain
15 Pediatric Allergy and Clinical Immunology Service, Hospital Sant Joan de Déu, Barcelona
16 Clinica San Carlo, Paderno Dugnano, Italy
17 Allergy Unit, Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland; Faculty of Medicine, University of Zurich, Zurich, Switzerland
18 Clinic for Dermatology and Allergology, Kantonsspital St Gallen, St Gallen, Switzerland.
19 School of Medicine, Institute for Applied Molecular Medicine (IMMA), Universidad CEU San Pablo, Madrid, Spain.
20 Instituto de Salud Carlos III, Madrid, Spain
21 Meyer Children’s University Hospital, Florence, Italy
22 Pediatric Unit, Policlinico Hospital. University of Messina-Italy
23 Charité Universitätsmedizin Berlin, Germany
24 Odense University Hospital, Odense Denmark
25 Evelina London Childrens Hospital, London, UK
26 Guy’s and St Thomas’ Hospital London, UK
27 King’s College London, UK
28 Koc University Hospital, Istanbul, Turkey
29 Federal University of São Paulo, Brazil
30 Department of Pediatrics, Division of Allergy and Immunology, The Children’s Hospital of Philadelphia, PA, USA
31 Sean N Parker Center for Allergy and Asthma Research, Stanford University, USA
32 Pulmonary, Allergy, Critical Care Medicine, Department of Medicine, Stanford University, USA
33 Department of Medical Sciences and Public Health, University of Cagliari, Italy
34 University College Cork, Ireland
35 Anaphylaxis Ireland (CEO)
36 Sechenov University,Moscow
37 Department of Dermatology and Allergy BiedersteinTechnische Universität München
38 Department of Allergy, Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital, Kanagawa, Japan
39 University Hospitals of Geneva, Switzerland
40 The Hospital for Sick Children, Toronto, Ontario
41University of Toronto, Ontario
42University Hospital of St. Pölten, Karl Landsteiner University of Health Sciences
43 University of Antwerp, Department of Immunology and Allergology, Antwerp, Belgium
44 Allergy Dept., Hospital Clinico San Carlos, Universidad Complutense, IdISSC, Madrid, Spain
45 Meyer Children’s University Hospital, Florence, Italy
46 Hans Christian Andersen Children’s Hospital, Odense University Hospital
47 Medical University of Vienna, Austria
48 University of Surrey, Guildford, UK
49 Department of Psychology, Aston University, Birmingham, UK.
50 Departments of Immunology and Dermatology/Allergology, University Medical Center Utrecht, Utrecht, the Netherlands
51 Department of Allergy and Clinical Immunology General Military Training Hospital, Thessaloniki, Greece
52 Universitaetsmedizin Berlin, Pediatric Respiratory Medicine, Immunology and Intensive Care Medicine, Germany
53 Biomedical Research Institute and University Hospital of Málaga
54 Imperial College London UK
55 Department of Allergy, Hospital Universitario 12 de Octubre, Madrid, Spain
56 Food Allergy Referral Centre, Department of Woman and Child Health, Padua University hospital , Padua , Italy
57 Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden
58 Sachs’ Children and Youth Hospital, Södersjukhuset, Stockholm, Sweden
59 University College Cork, Cork, Ireland
60 Allergy Department, 2nd Pediatric Clinic, University of Athens, Greece
61 Division of Infection, Immunity & Respiratory Medicine, University of Manchester, UK
62 Murdoch Children’s Research Institute, Melbourne, Australia
63 European Federation of Allergy and Airways Diseases Patient’s Associations, Belgium
64 Copenhagen University Hospital, Denmark
65 David Hide Centre, St Mary’s Hospital, Isle of Wight, United Kingdom
66 University of Southampton, Southampton, United Kingdom
67 Department of Pediatrics at the Icahn School of Medicine at Mount Sinai
68 Wroclaw Medical University, Department of Clinical Immunology, Wroclaw, Poland
69 The University of Edinburgh, Edinburgh, UK
70 Institute of Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, Medical University of Vienna
71 Amsterdam University Medical Centers, Location AMC, The Netherlands
72 Children’s Hospital Colorado, University of Colorado, Colorado, USA
73 Emory University and Children’s Healthcare of Atlanta
74 OLVG Hospital, Amsterdam, the Netherlands
Conflict of interest statement: a separate COI form has been submitted due to the long list of authors.
Abstract (237 words)
Background: The European Academy of Allergy and Clinical Immunology (EAACI) is in the process of updating the guidelines on the diagnosis and management of food allergy. The existing guidelines are based on a systematic review of the literature until 30th September 2012. Therefore, a new systematic review must be undertaken to inform the new guidelines. This systematic review aims to assess the accuracy of index tests to support the diagnosis of IgE-mediated food allergy.
Methods: The databases Cochrane CENTRAL (Trials), MEDLINE (OVID) and Embase (OVID) will be searched for diagnostic test accuracy studies from 1st October 2012 to 30th June 2021. Inclusion and exclusion criteria will be used to select appropriate studies. Data from these studies will be extracted and tabulated, and then reviewed for risk of bias and applicability using the QUADAS-2 tool. All evaluation will be done in duplicate. Studies with a high risk of bias and low applicability will be excluded. Meta-analysis will be performed if there are three or more studies of the same index test and food.
Results: A protocol for the systematic review and meta-analyses is presented and was registered using Prospero prior to commencing the literature search.
Discussion: Oral food challenges are the reference standard for diagnosis but involve considerable risks and resources. This protocol for systematic review aims to assess the accuracy of various tests to diagnose food allergy, which can be useful in both clinical and research settings.
Keywords: Food allergy, IgE-mediated, diagnosis, diagnostic tests, specific IgE, skin prick test, component-resolved diagnostics, basophil activation test, mast cell activation test
Key message: This is the protocol for the systematic review of the literature which will inform the update of the Food Allergy Guidelines of the European Academy of Allergy and Clinical Immunology (EAACI).