search
Back to results

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)

Primary Purpose

Birch Pollen Allergy, Grass Pollen Allergy, House Dust Mite Allergy

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
ALEX² test using the MAX 45k automated laboratory system
Sponsored by
MacroArray Diagnostics GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Birch Pollen Allergy

Eligibility Criteria

0 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Department of Dermatology and Venerology, Medical University of Graz
  • Allergy Outpatient Clinic Reumannplatz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Other

Other

Other

Other

Other

Other

Other

Arm Label

birch pollen allergy

grass pollen allergy

house dust mite allergy

cat allergy

bee venom allergy

vespid venom allergy

non-allergic individuals

Arm 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).

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).

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)

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Skin test
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)

Full Information

First Posted
June 15, 2020
Last Updated
April 21, 2022
Sponsor
MacroArray Diagnostics GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT04435678
Brief Title
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
Acronym
MADMAX
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
April 12, 2022 (Actual)
Study Completion Date
April 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MacroArray Diagnostics GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birch Pollen Allergy, Grass Pollen Allergy, House Dust Mite Allergy, Cat Allergy, Bee Venom Allergy, Vespid Venom Allergy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
839 (Actual)

8. Arms, Groups, and Interventions

Arm Title
birch pollen allergy
Arm Type
Other
Arm 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).
Arm Title
grass pollen allergy
Arm Type
Other
Arm 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).
Arm Title
house dust mite allergy
Arm Type
Other
Arm 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)
Arm Title
cat allergy
Arm Type
Other
Arm 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).
Arm Title
bee venom allergy
Arm Type
Other
Arm 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).
Arm Title
vespid venom allergy
Arm Type
Other
Arm 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).
Arm Title
non-allergic individuals
Arm Type
Other
Arm 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).
Intervention Type
Diagnostic Test
Intervention Name(s)
ALEX² test using the MAX 45k automated laboratory system
Intervention Description
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.
Primary Outcome Measure Information:
Title
diagnostic accuracy (sensitivity, specificity) of the MAX 45k/ALEX² IgE multiplex test
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Skin test
Description
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)
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Department of Dermatology and Venerology, Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Allergy Outpatient Clinic Reumannplatz
City
Vienna
ZIP/Postal Code
1100
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs