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

House Dust Mite Allergy Clinical Trial

— MADMAX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04435678
• Other study ID #: 32-332 ex 19/20
• Status: Completed
• Phase: N/A
• Start date: July 22, 2020
• Est. completion date: April 12, 2022

Study information

• Verified date: February 2022
• Source: MacroArray Diagnostics GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 839
• Est. completion date: April 12, 2022
• Est. primary completion date: April 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bee Venom Allergy
• Birch Pollen Allergy
• Cat Allergy
• Grass Pollen Allergy
• House Dust Mite Allergy
• Hypersensitivity
• Rhinitis, Allergic, Seasonal
• Vespid Venom Allergy

Intervention

Diagnostic Test:
• ALEX² test using the MAX 45k automated laboratory system
The ALEX² test system is a quantitative in vitro diagnostic (IVD) test for the measurement of allergen specific IgE (sIgE) and a semi-quantitative in vitro diagnostic test for the measurement of total IgE (tIgE) in human serum or plasma (exception EDTA plasma). The MAX 45k analyzer is intended for an automated in-vitro diagnostics use for quantitative determination of allergen specific Immunoglobulin E and semi-quantitative determination of total IgE. The MAX 45k is suitable for human serum or plasma (Heparin, Citrat, but no EDTA). MAX 45k is intended to be used only in conjunction with RAPTOR SERVER analysis software and ALEX based technology arrays.

Locations

Country	Name	City	State
Austria	Department of Dermatology and Venerology, Medical University of Graz	Graz
Austria	Allergy Outpatient Clinic Reumannplatz	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
MacroArray Diagnostics GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic accuracy (sensitivity, specificity) of the MAX 45k/ALEX² IgE multiplex test	Sensitivity and specificity of the sIgE status determined by the MAX 45k/ALEX² IgE multiplex test (positive, if =0.30 kUA/L) compared to allergy status according to clinical symptoms.	1 day
Secondary	Skin test	Sensitivity and specificity of the sIgE status determined by the MAX 45k/ALEX² IgE multiplex test compared to allergy status according to skin test results (specific for suspected allergy)	1 day