Clinical trial NCT04435678: Diagnostic Accuracy of the MADx Multi Array Xplorer (MAX 45k) Automated Laboratory System and the MADx Allergy Explorer Version 2 (ALEX²) - IgE Multiplex Test for the Diagnosis of Pre-defined Groups of Specific High-priority Allergens
Official title: Diagnostic Accuracy of the MADx Multi Array Xplorer (MAX 45k) Automated Laboratory System and the MADx Allergy Explorer Version 2 (ALEX²) - IgE Multiplex Test for the Diagnosis of Pre-defined Groups of Specific High-priority Allergens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birch Pollen Allergy
Grass Pollen Allergy
House Dust Mite Allergy
Cat Allergy
Bee Venom Allergy
Vespid Venom Allergy
Lead sponsor: MacroArray Diagnostics GmbH
Sponsor class: INDUSTRY
First posted: 2020-06-17
Enrollment: 839
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: About 20% of the general population are affected by an allergy - with an upward trend. Quite often, allergic people do not consider their disease as serious and suffer from subsequent complications, like allergic asthma, later in their life. The sooner the allergen source is identified, the sooner the therapeutic intervention (e.g. dietary recommendations, allergen avoidance, anti-inflammatory treatment or allergen immunotherapy) can be started. Cross-reactivity may also play an important role. Therefore, a comprehensive allergy test is essential for an optimal treatment of patients.

Modern multiplex testing is an individualized diagnostic approach, which may help to identify eligible patients for allergen immunotherapy and may identify risk groups by analyzing the sIgE profile. Until now, published data on the clinical usability of multiplex allergy diagnostic test systems are often limited. Even though, available studies show a good correlation between conventionally used multiplex or singleplex assays (ISAC or ImmunoCAP) and the new multiplex assay (ALEX and ALEX²), the results are often based on small sample sizes investigating many different allergens.

Therefore, this clinical performance study is conducted to evaluate the diagnostic accuracy of the ALEX² IgE multiplex test using the Multi Array Explorer (MAX 45k, MacroArray Diagnostics) automated laboratory system in comparison to a conventional IgE singleplex test system as well as clinical symptoms and skin prick test results in a total of 826 patients. Patients with the most common inhalant allergies (e.g. grass pollen, house dust mite or cat allergy) will be included as well as patients suffering from Hymenoptera venom allergy, which is the major cause of anaphylaxis.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects with suspicion of allergy
* Written consent of the participant (and/or his/her parent or legal representative) after being informed

Exclusion Criteria:

* Oral treatment with corticosteroids (\>5mg/day)
* Treatment with antihistamines (histamine (H1) receptor blockers)
* Hematological disease (coagulation disorders, anemia)

Primary outcomes:
measure: diagnostic accuracy (sensitivity, specificity) of the MAX 45k/ALEX² IgE multiplex test
timeFrame: 1 day
Secondary outcomes:
measure: Skin test
timeFrame: 1 day
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Dermatology and Venerology, Medical University of Graz
city: Vienna
country: Austria
facility: Allergy Outpatient Clinic Reumannplatz
Study officials:
References: