@article{d307cab3e67b4db2b6656572658b7606,
title = "Accurate and reproducible diagnosis of peanut allergy using epitope mapping",
abstract = "Background: Accurate diagnosis of peanut allergy is a significant clinical challenge. Here, a novel diagnostic blood test using the peanut bead-based epitope assay (“peanut BBEA”) was developed utilizing the LEAP cohort and then validated using two independent cohorts. Methods: The development of the peanut BBEA diagnostic test followed the National Academy of Medicine's established guidelines with discovery performed on 133 subjects from the non-interventional arm of the LEAP trial and an independent validation performed on 82 subjects from the CoFAR2 and 84 subjects from the POISED study. All samples were analyzed using the peanut BBEA methodology, which measures levels of IgE to two Ara h 2 sequential (linear) epitopes and compares their combination to a threshold pre-specified in the model development phase. When a patient has an inconclusive outcome by skin prick testing (or sIgE), IgE antibody levels to this combination of two epitopes can distinguish whether the patient is “Allergic” or “Not Allergic.” Diagnoses of peanut allergy in all subjects were confirmed by double-blind placebo-controlled food challenge and subjects{\textquoteright} ages were 7–55 years. Results: In the validation using CoFAR2 and POISED cohorts, the peanut BBEA diagnostic test correctly diagnosed 93% of the subjects, with a sensitivity of 92%, specificity of 94%, a positive predictive value of 91%, and negative predictive value of 95%. Conclusions: In validation of the peanut BBEA diagnostic test, the overall accuracy was found to be superior to existing diagnostic tests for peanut allergy including skin prick testing, peanut sIgE, and peanut component sIgE testing.",
keywords = "BBEA, diagnosis, epitopes, IgE, peanut",
author = "Mayte Su{\'a}rez-Fari{\~n}as and Maria Suprun and Paul Kearney and Robert Getts and Galina Grishina and Clive Hayward and David Luta and Alex Porter and Marc Witmer and {du Toit}, George and Gideon Lack and Chinthrajah, {Rebecca Sharon} and Galli, {Stephen J.} and Kari Nadeau and Sampson, {Hugh A.}",
note = "Funding Information: Dr. Su{\'a}rez‐Fari{\~n}as received research funding to Mount Sinai by a grant from AllerGenis LLC. Ms. Suprun and Grishinahave nothing to disclose. Dr. Kearney, Mr. Hayward, Mr. Luta, Dr. Porter, Mr. Witmerare employees or paid consultants to AllerGenis. Dr. Getts is an employee of Genisphere LLC and scientific consultant of AllerGenis LLC; in addition, Dr. Getts has a patent PCT/US15/020715 (WO) pending. Dr. du Toit has received research support from the NIAID (NO1‐AI‐15416 [contract] and UM1AI109565 [grant], covering salary) and the UK Food Standards Agency; has received a contribution to NIAID contract/grant from the Food Allergy Research & Education; has received a contribution to KCL Division of Asthma Allergy &Lung Biology from Medical Research Council (MRC) & Asthma UK Centre; has received the Biomedical Research Centre (BRC) award to Guy's and St Thomas{\textquoteright} National Health Service (NHS) Foundation from the UK Department of Health through the National Institute for Health Research (NIHR); and has received support for pediatric allergy clinical trial's unit from the National Peanut Board. Dr. Lack has received research support from the NIAID (NO1‐AI‐15416 [contract] and UM1AI109565 [grant]), and UK Food Standards Agency; is on the DBV Technologies scientific advisory board; has received a contribution to NIAID contract/grant from Food Allergy Research and Education; has received a contribution to KCL Division of Asthma Allergy & Lung Biology from MRC & Asthma UK Centre; has received the BRC award to Guy's and St Thomas{\textquoteright} NHS Foundation from the UK Department of Health through NIHR; has received support for pediatric allergy clinical trial's unit from the National Peanut Board; has received discounted Bamba peanut snack from Osem; and has stock/stock options in DBV Technologies. Dr. Chinthrajah reports grants from NIAID, CoFAR, Aimmune, DBV Technologies, Astellas, Regeneron, FARE, and is an Advisory Board member for Alladapt, Genentech, Novartis, Sanofi, and received personal fees from Nutricia. Dr. Nadeau reports grants from National Institute of Allergy and Infectious Diseases (NIAID), National Heart, Lung, and Blood Institute (NHLBI), and National Institute of Environmental Health Sciences (NIEHS); Food Allergy Research & Education (FARE), Director of World Allergy Organization (WAO) Center of Excellence at Stanford; Advisor at Cour Pharma; Co‐founder of Before Brands, Alladapt, Latitude, and IgGenix; National Scientific Committee member at Immune Tolerance Network (ITN) and National Institutes of Health (NIH) clinical research centers; DSMB member for NHLBI, US patents for basophil testing, multifood immunotherapy and prevention, monoclonal antibody from plasmoblasts, and device for diagnostics. Dr. Galli reports grants from NIH, including NIAID U19AI104209. Dr. Sampson reports grants from Immune Tolerance Network; NIAID/NIH, personal fees from N‐Fold Therapeutics and DBV Technologies, outside the submitted work; and Mount Sinai has licensed the technology for a bead‐based epitope assay for food‐allergen epitope analyses to AllerGenis LLC. Dr. Sampson serves as an unpaid Board of Directors member and advisor to AllerGenis LLC. Funding Information: The authors would like to acknowledge the contributions of the CoFAR investigators (Scott Sicherer, Robert Wood, Wesley Burks, Stacie Jones, and Donald Leung); POISED investigator Mindy Tsai; and funding from the Sean N. Parker Center for Allergy and Asthma Research at Stanford University. H.S. was funded in part by a grant from National Institute of Allergy and Infectious Diseases (NIAID, AI‐66738) and the David H. and Julia Koch Research Program in Food Allergy Therapeutics, and H.S. and M.SF. were funded in part by a grant from AllerGenis LLC. M.S. was funded by the Integrated Pharmacological Sciences Training Program grant from the National Institute of General Medical Sciences (NIGMS, T32GM062754). Publisher Copyright: {\textcopyright} 2021 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.",
year = "2021",
month = dec,
doi = "10.1111/all.14905",
language = "English",
volume = "76",
pages = "3789--3797",
journal = "Allergy: European Journal of Allergy and Clinical Immunology",
issn = "0105-4538",
publisher = "John Wiley and sons",
number = "12",
}