Protocol for a systematic review of the diagnostic test accuracy of tests for IgE-mediated food allergy

Jon Genuneit*, Sashini Jayasinghe, Carmen Riggioni, Rachel Louise Peters, Derek K. Chu, Daniel Munblit, Robert J. Boyle, George Du Toit, Isabel Skypala, Alexandra F. Santos, Cezmi A. Akdis, Alberto Alvarez-Perea, Montserrat Alvaro Lozano, Riccardo Asero, Barbara Ballmer-Weber, Domingo Barber, Simona Barni, Giovanni Battista Pajno, Kirsten Beyer, Carsten Bindslev-JensenHelen Brough, Betul Buyuktiryaki, Lucila Camargo Lopes de Oliveira, Antonella Cianferoni, R. Sharon Chinthrajah, Sean N. Parker, Stefano Del Giacco, Audrey DunnGalvin, Bernadette Eberlein, Motohiro Ebisawa, Philippe Eigenmann, Thomas Eiwegger, Margaretha Faber, Montserrat Fernandez-Rivas, Mary Feeney, Helen Fisher, Mattia Giovannini, Susanne Halken, Karin Hoffmann-Sommergruber, Hannah Jaumdally, Christina J. Jones, Rebecca Knibb, Edward Knol, George N. Konstantinou, Marta Krawiec, Susanne Lau, Lina Mayorga, M. Andreina Marques-Mejias, Rosan Meyer, Beatriz Moya,

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


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 30 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 1 October 2012 to 30 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 evaluations 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.

Original languageEnglish
Article numbere13684
JournalPediatric Allergy and Immunology
Issue number1
Early online date21 Oct 2021
Publication statusPublished - Jan 2022

Bibliographical note

The submitted version available at 10.22541/au.162677307.71576556/v1 was accepted for publication on 9 Sept 2021.

The final published version can be found at:
Genuneit, J, Jayasinghe, S, Riggioni, C, et al; on behalf of the EAACI Food Allergy Guidelines Expert Group, the EAACI Research, Outreach Committee Food Allergy Group. Protocol for a systematic review of the diagnostic test accuracy of tests for IgE-mediated food allergy. Pediatr Allergy Immunol. 2021; 00: 1– 8.


  • basophil activation test
  • component-resolved diagnostics
  • diagnosis
  • diagnostic tests
  • food allergy
  • IgE-mediated
  • mast cell activation test
  • skin prick test
  • specific IgE


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