Diagnostic accuracy and safety of threshold oral food challenges (TOFCs) in infants under 12 months with suspected peanut allergy prior to starting oral immunotherapy (OIT) in the Australian ADAPT program across 10 public hospital sites (April 2024–October 2025).
Of 778 infants who underwent TOFC, 34.8% (271/778) had negative results despite prior reactions and sensitization — enabling early delabeling. TOFCs were positive in 65.2% (507/778); anaphylaxis occurred in 12.0% of positive OFCs (61/507, 7.8% overall) but was safely managed. Among 394 infants starting OIT, 97.5% (384/394) successfully initiated treatment below the TOFC-determined threshold.
Retrospective chart review design limits data completeness and causal inference. The study population is infants with only grade 1–2 prior reactions, so findings may not generalize to those with more severe reactions. Skin prick test and Ara h 2 sIgE did not predict reaction threshold or severity, limiting the utility of biomarkers to avoid OFC.
Routine OFC before peanut OIT — or before deciding on allergen avoidance — should be strongly considered in infants, as over one-third may be incorrectly labeled allergic. Sensitization markers (SPT, Ara h 2 sIgE) alone are insufficient to confirm allergy or determine OIT starting dose.
