Biomarker: M012-IgE Aureobasidi pullulans

Overview

M012-IgE measures serum-specific immunoglobulin E (IgE) antibodies directed against the mold Aureobasidium pullulans. IgE is involved in immediate hypersensitivity reactions, including allergic rhinitis and asthma. A detectable or elevated result indicates sensitization to the mold but does not by itself establish symptomatic allergy or predict reaction severity. The test may support evaluation of suspected mold-related respiratory allergy when interpreted with the patient’s clinical history and other allergy-testing results.

Clinical Use Cases

Evaluation of suspected IgE-mediated sensitivity to Aureobasidium pullulans.
Investigation of allergic rhinitis, asthma, or other respiratory symptoms associated with mold exposure.
Identification of mold sensitization when skin-prick testing is unsuitable, contraindicated, or affected by medication use.
Supplementary assessment of patients with asthma, because human studies have reported an association between A. pullulans sensitization and more severe asthma.
Research assessment of immune reactivity to A. pullulans allergens in human populations.

Specimen Types

Venous blood, typically submitted as serum.
Skin-prick testing with A. pullulans extract is an alternative assessment of sensitization, but it is not the M012-IgE blood test.

Measurement Methods

In-vitro quantitative allergen-specific IgE immunoassay.
Fluorescence-based immunoassay platforms, in which patient IgE binds to immobilized allergen and the resulting signal is measured.
Skin-prick testing with fungal extract as a separate, in-vivo method for assessing immediate hypersensitivity.

Test Preparation and Influencing Factors

Fasting is generally not required for an allergy blood test.
Inform the healthcare professional about all medications and supplements.
Do not stop antihistamines or other prescribed medicines unless instructed by a healthcare professional.
Antihistamines can interfere with skin-prick testing, but they generally do not prevent collection of a serum-specific IgE sample.
Results should be interpreted with exposure history, symptoms, physical findings, and other allergy tests.
A positive result indicates sensitization and does not prove that exposure causes symptoms or indicate how severe symptoms will be.
Assay methods, reporting units, reference ranges, and classification thresholds may differ between laboratories.
Total IgE concentration, age, atopic status, and concurrent allergic or inflammatory conditions may affect interpretation of the result.
A negative result does not completely exclude clinically relevant allergy, particularly when exposure history and symptoms are strongly suggestive.