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
Condition: Birch Pollen Allergy; Grass Pollen Allergy; House Dust Mite Allergy; Cat Allergy; Bee Venom Allergy; Vespid Venom Allergy
MeSH terms: Rhinitis, Allergic, Seasonal; Dust Mite Allergy; Hypersensitivity; Venom Hypersensitivity
Study type: Interventional

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.
    


Intervention name(s): ALEX² test using the MAX 45k automated laboratory system
Intervention type(s): Diagnostic Test
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic