Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559319
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
The Basophil Activation Test For Egg Allergy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation Of the Basophil Activation Test in Child Egg Allergy Diagnosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAT
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 035KUL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None