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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

839

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jul 2020

Geographic Reach

1 country

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

June 15, 2020

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed

1 month until next milestone

Study Start

First participant enrolled

July 22, 2020

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2022

Completed

Last Updated

April 22, 2022

Status Verified

February 1, 2022

Enrollment Period

1.7 years

First QC Date

June 15, 2020

Last Update Submit

April 21, 2022

Conditions

Birch Pollen Allergy Grass Pollen Allergy House Dust Mite Allergy Cat Allergy Bee Venom Allergy Vespid Venom Allergy

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

Skin test
1 day

Study Arms (7)

birch pollen allergy

OTHER

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).