Diagnostic Accuracy of the MADx Multi Array Xplorer (MAX 45k) Automated Laboratory System and the MADx Allergy Explorer Version 2 (ALEX ) - IgE Multiplex Test for the Diagnosis of Pre-defined Groups of Specific High-priority Allergens

  • STATUS
    Recruiting
  • End date
    May 9, 2022
  • participants needed
    826
  • sponsor
    MacroArray Diagnostics GmbH
Updated on 9 September 2021

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 ALEX), 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 ALEX 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.

Details
Condition Cat Allergy, Vespid Venom Allergy, House Dust Mite Allergy, allergy to cats, allergy to grass pollen, Bee Venom Allergy, Grass Pollen Allergy, Birch Pollen Allergy
Treatment ALEX² test using the MAX 45k automated laboratory system
Clinical Study IdentifierNCT04435678
SponsorMacroArray Diagnostics GmbH
Last Modified on9 September 2021

Eligibility

Yes No Not Sure

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)
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