Accuracy of bead-based epitope assay testing for peanut allergy diagnosis: Real-world pediatric population study

Abstract

Background: Peanut allergy accounts for 25% of children with food allergy, but current testing has a poor positive predictive value (PPV) and low accuracy, with peanut allergy overdiagnoses estimated to be greater than 60% in clinical settings. New methods for peanut allergy diagnosis through bead-based epitope assay (BBEA) testing with Ara h 2.008 and Ara h 2.019 epitopes have retrospectively demonstrated improved accuracy in peanut allergy diagnosis.

Objective: To prospectively evaluate BBEA testing for peanut allergy in a real-world racially diverse clinical population with determination of BBEA testing accuracy, PPV, negative predictive value (NPV), sensitivity, and specificity.

Methods: Patients from a tertiary food allergy clinic underwent standard testing for peanut allergy, including skin prick testing, specific IgE testing, and evaluation of peanut IgE component (Ara h 1, 2, 3, 6, 8, and 9) testing. BBEA evaluation to the Ara h 2.008 and Ara h 2.019 epitopes was performed on all patients, and oral food challenges were offered to patients with indeterminate standard testing.

Results: In this real-world population study, BBEA testing has a 96% accuracy, 96% PPV, 94% NPV, 98% sensitivity, and 89.5% specificity. For children younger than 2 years and Black children, the accuracy, PPV, NPV, sensitivity, and specificity were 100%. The NPV was 100% in patients with no peanut ingestion or reaction history.

Conclusion: The use of BBEA testing has a higher diagnostic accuracy compared with standard food allergy testing and may decrease need for unnecessary oral food challenges in clinical settings.