QUANTIFICATION OF BASOPHIL-HISTAMINE RELEASE BY EIA

HISTAMINE IS AN IMPORTANT BIOCHEMICAL MEDIATOR THAT CAUSES ALLERGIC SYMPTOMS. IGE MOLECULES HAVE A HIGH AFFINITY FOR RECEPTORS ON BASOPHILS. THE PRESENCE OF SPECIFIC ALLERGENS WILL BRIDGE IGE BOUND ON BASOPHIL AND INITIATE A CHAIN OF EVENTS LEADING TO HISTAMINE RELEASE. QUANTIFYING BASOPHIL-HISTAMINE RELEASE ESSENTIALLY MEASURES THE CELL-BOUND, ALLERGEN-SPECIFIC IGE AND WILL ALLOW EVALUATION OF A PATIENT'S ALLERGIC STATUS. RESULTS INDICATE THE PATIENT'S BIOLOGICAL ACTIVE-CELL SENSITIVITY TO ALLERGENS. THE TEST MAY BE USED TO:(1) IDENTIFY SPECIFIC ALLERGIES OF PATIENTS, (2) SUGGEST INITIAL SAFE DOSAGES OF IMMUNOTHERAPY,(3) MONITOR PROGRESS OF IMMUNOTHERAPY, AND (4) ESTIMATE ALLERGENIC EXTRACT POTENCY. PHASE I STUDIES SEEK TO DEVELOP A PROCEDURE TO RELEASE HISTAMINE FROM SENSITIZED BASOPHILS UNDER CONTROL CONDITIONSAND AN IMMUNOASSAY TO QUANTITATE HISTAMINE BY ENZYME IMMUNOASSAY (EIA) TECHNIQUES. POLYCLONAL ANTIBODY SPECIFIC TO HISTAMINE HAS BEEN DEVELOPED. ANIMAL BIOTECH CORPORATIONWILL AFFINITY-PURIFY THE ANTIHISTAMINE ANTIBODY AND CONJUGATE THE ENZYME HORSERADISH PEROXIDASE (HRPO) TO THE ANTIBODY. THE AMOUNT OF HISTAMINE IN A SAMPLE WILL BE MEASURED BY THE INHIBITION OF ANTIHISTAMINE-HRPO BINDING TO MICROTITER-WELL HISTAMINE. PHASE II WILL INCLUDE ALL THE CLINICAL STUDIES TO CORRELATE DATA WITH THE SKIN TEST, RAST,AND MONITOR PROGRESS OF IMMUNOTHERAPY.