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 (MADMAX)

MacroArray Diagnostics (MADx)

Status: Completed

Conditions: Cat Allergy; House Dust Mite Allergy; Birch Pollen Allergy; Vespid Venom Allergy; Bee Venom Allergy; Grass Pollen Allergy

Treatments: Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system

Study type: Interventional

Funder types: Industry

Identifiers

NCT04435678

32-332 ex 19/20

Details and patient eligibility

About

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.

Enrollment: 839 patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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839 participants in 7 patient groups

birch pollen allergy

Other group

Description:

106 patients with suspicion of birch pollen allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed. Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).

Treatment:

Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system

grass pollen allergy

Other group

Description:

106 patients with suspicion of grass pollen allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed. Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).

Treatment:

Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system

house dust mite allergy

Other group

Description:

148 patients with suspicion of house dust mite allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed. Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system)

Treatment:

Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system

cat allergy

Other group

Description:

106 patients with suspicion of cat allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed. Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).

Treatment:

Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system

bee venom allergy

Other group

Description:

106 patients with suspicion of bee venom allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and an intradermal test will be performed. Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).

Treatment:

Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system

vespid venom allergy

Other group

Description:

106 patients with suspicion of vespid venom allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and an intradermal test will be performed. Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).

Treatment:

Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system

non-allergic individuals

Other group

Description:

148 non-allergic individuals will be included in the study. They should have no symptoms that could be related to inhalant allergy or Hymenoptera venom allergy, negative skin test results and undetectable IgE levels. Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).

Treatment:

Diagnostic Test: ALEX² test using the MAX 45k automated laboratory system