The Basophil Activation Test For Egg Allergy

Active, not recruiting

• Conditions: Food Allergy

• Registration Number: NCT06559319
• Lead Sponsor: Xia Peng

Brief Summary

In this study, basophil activation test (BAT) established by the investigators' lab was evaluated for its sensitivity and specificity in child egg allergy diagnosis. Children with suspected IgE mediated allergy to egg will be recruited in the study. Specific IgE to egg allergen and BAT will be detected. The diagnostic accuracy of the BAT will be assessed against clinical diagnosis based on history, clinical symptoms and laboratory results.

Detailed Description

In china, the prevalence of food allergy in in preschool children was about 7%. Diagnosis of food allergy is mainly based on a combination of clinical history, clinical manifestations and related supplementary examinations, including skin prick testing (SPT), serum specific IgE testing (sIgE), and oral food challenge (OFC). Although OFC is the gold standard for allergy diagnosis, it is rarely conducted in clinic for the low safety. Until now, serum specific IgE assays against allergen are the most commonly used in vitro diagnostic approach in China. However, specific-IgEs are sensitive, but not specific for diagnosis of food allergy. Moreover, food allergy could not be excluded when sIgE results are negative (\<0.35KU/L). Thus, more accurate and safer test is needed. BAT was shown to have good accuracy for food allergy diagnosis. BAT is an ex vivo functional assay that measures by flow cytometry the degree of basophil activation after stimulation with an allergen. However, experimental strategies for BAT reported in the literatures are different. Some research even used 12 kinds of antibodies to identity basophils. In previous study, the investigators established BAT using 4 kinds of antibodies. Basophils could be distinguished well from other cells. In this study, children aged 4 months to 6 years who visit pediatric and emergency department, and are suspected with egg allergy will be included in study. Detailed information about clinical history and manifestations will be collected. Serum sIgE to food and BAT will be detected. The proposed study intends to analyze sensitivity and specificity of the established BAT according to the clinical comprehensive diagnosis results, and evaluate its efficacy to diagnose food allergy in children.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-10
• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-15
• Study First Posted: 2024-08-19
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2027-03-25
• Study Completion: 2027-03-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

Not provided

Exclusion Criteria

• 1.Patients with hematological tumors, autoimmune diseases, organ transplantation, and immunodeficiency diseases
• 2.Take immunosuppressants, immunomodulators, statins, and inject anesthetics within 3 weeks

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Specificity of the BAT	2 days	Specificity is defined as the capacity for BAT to have a negative result when comprehensive diagnosis result is also negative.
Sensitivity of the BAT	2 days	Sensitivity of the BAT compare to clinical comprehensive diagnosis with a threshold value of 5% for the BAT in a population of child egg allergy.; Sensitivity is defined as the capacity for BAT to have a positive result when comprehensive diagnosis result is also positive

Trial Locations

Locations (1)

Shanghai General Hospital; 🇨🇳 Shanghai, China