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Basophil Activation Test for Allergy Diagnosis
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A Streamlined Strategy for Basophil Activation Testing in a Multicenter Phase III Clinical Trial.

Mayte Suárez-Fariñas1, Alexander Grishin2, Rihane Arif-Lusson3

  • 1Icahn Institute for Genomics and Multiscale Biology, Icahn School of Medicine at Mount Sinai, New York, NY; Center for Biostatistics, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.

The Journal of Allergy and Clinical Immunology. in Practice
|September 16, 2024
PubMed
Summary
This summary is machine-generated.

A streamlined basophil activation test (sBAT) shows promise for predicting peanut allergy outcomes in multicenter trials. This method aids in assessing allergic patients and predicting oral food challenge results.

Keywords:
Basophil activation testFood allergyMulticenter trialOral food challengePeanut allergy

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Area of Science:

  • Immunology
  • Allergy Research
  • Clinical Trials

Background:

  • The basophil activation test (BAT) has faced limitations in clinical research due to technical challenges.
  • Novel streamlined approaches, such as the streamlined basophil activation test (sBAT) with ready-to-use reagents, offer improved flexibility for clinical implementation.

Purpose of the Study:

  • To assess the feasibility of implementing sBAT in a multicenter clinical trial setting.
  • To evaluate sBAT's utility in predicting outcomes of peanut oral food challenges within the EPITOPE trial.

Main Methods:

  • Whole blood samples from 241 children (1-3 years) in the EPITOPE study were analyzed using sBAT.
  • A machine learning approach integrated sBAT data, clinical characteristics, and peanut-specific IgE to predict challenge outcomes.
  • Prediction models were developed using randomly split training and validation datasets.

Main Results:

  • Basophil activation markers (CD203c, CD63) correlated with eliciting dose (ED) and severity of peanut reactions.
  • sBAT demonstrated high sensitivity (0.85-0.86) in predicting ED and epinephrine use, with moderate specificity (0.60-0.80).
  • While not improving prediction of severe reactions alone, sBAT combined with other data enhanced prediction of higher EDs (>300 mg).

Conclusions:

  • Streamlined basophil activation test (sBAT) facilitates multicenter trial implementation.
  • sBAT retains the potential of traditional BAT for characterizing allergic patients.
  • sBAT shows promise in predicting outcomes of oral food challenges in peanut allergy.