Bee Venom Allergy, Birch Pollen Allergy, Cat Allergy, Grass Pollen Allergy, House Dust Mite Allergy, Vespid Venom Allergy
Conditions
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.
Interventions
DIAGNOSTIC_TESTALEX² 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.
Sponsors
MacroArray Diagnostics GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 100 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diagnostic accuracy (sensitivity, specificity) of the MAX 45k/ALEX² IgE multiplex test | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin test | 1 day | 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) |
Countries
Austria
Outcome results
None listed