This study will evaluate whether blood tests that measure IgE antibodies to two shrimp proteins, tropomyosin and hemocyanin, can help diagnose shrimp allergy in children. Children with suspected IgE-mediated shrimp allergy will undergo oral food challenge, skin prick testing, and blood sampling. Oral food challenge results will be used as the reference standard to determine whether these tests can accurately identify true shrimp allergy and help improve diagnosis in clinical practice.
Children aged 1 to 16 years.
Evaluated at the Allergy Unit of Children's Hospital 1.
Clinical history suggestive of IgE-mediated shrimp allergy based on EAACI 2023 criteria, including at least 1 typical allergic symptom (urticaria, angioedema, vomiting, abdominal pain, diarrhea, cough, wheezing, dyspnea, or hypotension), symptom onset within 2 hours after shrimp ingestion, and recurrence on at least 2 separate exposures.
Parent or legal guardian able to provide written informed consent; child assent obtained when appropriate.
Acute illness at the time of enrollment or challenge, including acute respiratory infection, acute gastrointestinal infection, or acute asthma exacerbation.
Severe chronic disease, including malignancy, severe liver or kidney disease, primary immunodeficiency, or significant heart disease affecting hemodynamic status.
Mental or behavioral disorder that prevents completion of study procedures.
Use of immunosuppressive medication (oral corticosteroids, cytotoxic drugs, or biologic agents) within 4 weeks before enrollment, or intravenous immunoglobulin within the previous 3 months.
Single group
Oral Food Challenge (OFC)
Diagnostic testOral food challenge with shrimp performed according to the study protocol to confirm or exclude IgE-mediated shrimp allergy in children with suspected shrimp allergy. To standardize the challenge material, black tiger shrimp (Penaeus monodon) will be used in all participants. Additional oral food challenges using other shrimp species may be performed when the clinical history suggests reactions to a different shrimp species. The oral food challenge result serves as the reference standard for diagnostic evaluation in this study.
Skin Prick Test
Diagnostic testSkin prick testing performed as part of the diagnostic evaluation in children with suspected IgE-mediated shrimp allergy.
Recombinant Tropomyosin- and Hemocyanin-Specific IgE Measurement
Diagnostic testBlood testing to measure specific IgE to recombinant tropomyosin and hemocyanin as part of the diagnostic evaluation of suspected shrimp allergy.
Oral Food Challenge-Confirmed IgE-Mediated Shrimp Allergy
Participants will be classified as having true IgE-mediated shrimp allergy if the oral food challenge is positive according to the study protocol. A negative oral food challenge indicates shrimp tolerance. Oral food challenge results will be used as the reference standard for subsequent diagnostic performance analyses.
Diagnostic Accuracy of Recombinant Tropomyosin-Specific IgE for Oral Food Challenge-Confirmed Shrimp Allergy
Diagnostic performance of recombinant tropomyosin-specific IgE will be evaluated against oral food challenge results, including receiver operating characteristic analysis, area under the curve, optimal cutoff, sensitivity, specificity, positive predictive value, and negative predictive value.
Diagnostic Accuracy of Recombinant Hemocyanin-Specific IgE for Oral Food Challenge-Confirmed Shrimp Allergy
Diagnostic performance of recombinant hemocyanin-specific IgE will be evaluated against oral food challenge results, including receiver operating characteristic analysis, area under the curve, optimal cutoff, sensitivity, specificity, positive predictive value, and negative predictive value.
Diagnostic Accuracy of a Combined Model Incorporating Recombinant Tropomyosin-Specific IgE, Recombinant Hemocyanin-Specific IgE, Clinical History, and Skin Prick Test
A combined diagnostic model using recombinant tropomyosin-specific IgE, recombinant hemocyanin-specific IgE, clinical history suggestive of shrimp allergy, and skin prick test results will be evaluated against oral food challenge results. Model performance will include receiver operating characteristic analysis and area under the curve.
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University of Medicine and Pharmacy at Ho Chi Minh City
Lead sponsor
Children's Hospital Number 1, Ho Chi Minh City, Vietnam
Collaborator
