Premium
An algorithm for diagnosing IgE‐mediated food allergy in study participants who do not undergo food challenge
Author(s) -
Kelleher Maeve M.,
Jay Nicola,
Perkin Michael R.,
Haines Rachel H.,
Batt Rebecca,
Bradshaw Lucy E.,
Montgomery Alan A.,
Chalmers Joanne R.,
Williams Hywel C.,
Boyle Robert J.
Publication year - 2020
Publication title -
clinical and experimental allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.462
H-Index - 154
eISSN - 1365-2222
pISSN - 0954-7894
DOI - 10.1111/cea.13577
Subject(s) - medicine , food allergy , allergy , sensitization , oral food challenge , randomized controlled trial , egg allergy , algorithm , immunology , computer science
Background Food allergy diagnosis in clinical studies can be challenging. Oral food challenges (OFC) are time‐consuming, carry some risk and may, therefore, not be acceptable to all study participants. Objective To design and evaluate an algorithm for detecting IgE‐mediated food allergy in clinical study participants who do not undergo OFC. Methods An algorithm for trial participants in the Barrier Enhancement for Eczema Prevention (BEEP) study who were unwilling or unable to attend OFC was developed. BEEP is a pragmatic, multi‐centre, randomized‐controlled trial of daily emollient for the first year of life for primary prevention of eczema and food allergy in high‐risk infants (ISRCTN21528841). We built on the European iFAAM consensus guidance to develop a novel food allergy diagnosis algorithm using available information on previous allergenic food ingestion, food reaction(s) and sensitization status. This was implemented by a panel of food allergy experts blind to treatment allocation and OFC outcome. We then evaluated the algorithm's performance in both BEEP and Enquiring About Tolerance (EAT) study participants who did undergo OFC. Results In 31/69 (45%) BEEP and 44/55 (80%) EAT study control group participants who had an OFC the panel felt confident enough to categorize children as “probable food allergy” or “probable no food allergy”. Algorithm‐derived panel decisions showed high sensitivity 94% (95%CI 68, 100) BEEP; 90% (95%CI 72, 97) EAT and moderate specificity 67% (95%CI 39, 87) BEEP; 67% (95%CI 39, 87) EAT. Sensitivity and specificity were similar when all BEEP and EAT participants with OFC outcome were included. Conclusion We describe a new algorithm with high sensitivity for IgE‐mediated food allergy in clinical study participants who do not undergo OFC. Clinical Relevance This may be a useful tool for excluding food allergy in future clinical studies where OFC is not conducted.