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ALEX3® Allergen Test

The ALEX3® Allergen Test is an innovative diagnostic tool designed to identify and quantify allergen-specific IgE antibodies in the blood. This test is crucial in diagnosing and managing allergic diseases, including allergic rhinitis, asthma, atopic dermatitis, and food allergies. By detecting specific IgE antibodies against a wide range of allergens, the ALEX3® test helps healthcare providers identify the underlying triggers of allergic reactions and tailor appropriate treatment plans for affected individuals.

The ALEX3® test allows for IgE multiplexing of more than 300 allergens (extracts and molecular allergens) from a small volume serum sample.

The panel includes pollen, mites, cat and dog fur, insect venoms, molds and yeasts, food, or latex, supplemented with total IgE.

Compared to earlier panels (e.g., ALEX2®) ALEX3® features an expanded number of molecular allergens, offering higher diagnostic accuracy and improved assessment of the clinical relevance of sensitizations.

The ALEX3® Allergen Test offers several clinical applications in the diagnosis and management of allergic diseases:

  • Identification of Allergic Triggers: The test allows for the identification of specific allergens to which an individual is sensitized, including common inhalant allergens (such as pollen, dust mites, and animal dander) and food allergens (such as nuts, eggs, and shellfish). This information is crucial for implementing allergen avoidance strategies and minimizing exposure to triggers.
  • Assessment of Allergy Severity: The quantitative measurement of allergen-specific IgE antibodies provided by the ALEX3® test can help assess the severity of allergic sensitization. Higher levels of specific IgE antibodies may correlate with increased symptom severity and the likelihood of allergic reactions upon exposure to the corresponding allergen. The molecular analysis of ALEX3® further enables the differentiation between primary allergy and cross-reactivity, which is particularly important in clinical practice.
  • Monitoring Allergen Immunotherapy (AIT): The ALEX3® Allergen Test can monitor the efficacy of allergen immunotherapy (AIT), a treatment approach to desensitize individuals to specific allergens. By tracking changes in allergen-specific IgE levels over time, healthcare providers can evaluate the effectiveness of AIT and adjust treatment protocols as needed.
Clinical Significance of the ALEX3® Allergen Test

The ALEX3® Allergen Test offers several clinical benefits for both patients and healthcare providers:

  • Personalized Treatment Approach: By identifying specific allergens to which an individual is sensitized, the test enables healthcare providers to develop customized treatment plans tailored to each patient's unique sensitivities and symptomatology.
  • Improved Patient Outcomes: Targeted allergen avoidance strategies and optimized treatment regimens based on the ALEX3® test results can improve symptom control, enhance quality of life, and reduce healthcare utilization for patients with allergic diseases.
  • Cost-Effective Management: Early identification of allergen sensitivities using the ALEX3® test can help prevent unnecessary diagnostic testing, minimize exposure to allergens, and facilitate targeted interventions, ultimately leading to cost savings in managing allergic diseases.
ALEX3® allergen profile

Detecting allergen-specific IgE antibodies in serum is crucial in diagnosing type 1 allergies. Conventional determination of individual allergens is often an expensive and lengthy procedure for patients with multiple allergen sensitizations or ambiguous clinical symptoms. A comprehensive allergen screening provides a clear picture of the patient‘s sensitization profile. Thus, it is a powerful tool for correctly diagnosing and preventing allergen exposure. The ALEX3® Allergy Explorer enables the simultaneous measurement of specific IgE against hundreds of allergens, with particular emphasis on next-generation molecular allergens. Compared to previous panels, ALEX3® includes a significantly higher number of molecular allergens, especially in foods, mites, and venoms, substantially improving diagnostic accuracy.

The method

ALEX3® Allergy Explorer is a quantitative solid-phase immunoassay. Specific IgE antibodies from the patient’s serum bind to the allergens (extracts and/or molecular components) on the macroarray. Adding a CCD-inhibitor reduces unspecific reactions and thus increases the test’s specificity. Colorimetric analysis is used to detect bound IgE antibodies. Test results for allergen-specific IgE are reported quantitatively in kUA/l.

The ALEX3® IgE allergen panel consists of more than 300 allergens, with a significantly increased number of molecular allergens (components) compared to previous versions. This makes it one of the most comprehensive and advanced molecular allergy panels available, offering greater diagnostic accuracy, particularly for food allergies and cross-reactivity.

As the evolution of previous panels, ALEX3® includes an expanded spectrum of molecular allergens, enhancing the ability to differentiate between primary allergy and cross-reactive responses. Because molecular allergens can be reproduced with high precision and purity, they provide improved and more reproducible sensitivity. Testing based on well-defined molecular allergen components helps distinguish true allergen-specific allergy from reactions due to shared molecular structures across different allergen families.

In addition, the ALEX3® allergen panel includes recombinant molecular allergens free of cross-reactive carbohydrate determinants (CCD) and incorporates a CCD-blocking agent, reducing non-specific reactions and increasing test specificity.

The advantages of the ALEX3® test are:
  1. The simultaneous determination of more than 300 IgE - a wide range of allergens (grasses, trees and weeds), epithelial tissue of animals (domestic and farm), mites (house dust), plant foods (fruits, vegetables, mushrooms, nuts, seeds, legumes plants, grains and spices), animal foods (meat, milk, egg, fish and seafood), microorganisms and spores (molds and yeasts), insects and toxins (bee, wasp, cockroach), latex, etc. With a significantly increased number of molecular allergens, particularly in foods and mites.
  2. The test gives a quantitative expression of the result.
  3. CCD inhibition included increasing specificity. Most allergens of plant and insect origin contain cross-reactive carbohydrate determinants (CCDs). Antibodies directed against them cross-react to all proteins containing CCD epitopes. Approximately 25% of patients have anti-CCD IgE, resulting in very positive s IgE results, which reduces the test's specificity. By including a potent CCD inhibitor during sample incubation, non-specific reactions are reduced, and specificity is increased.
  4. Enables the implementation of specific immunotherapy, with greater accuracy due to the extensive molecular analysis.
  5. Risk assessment for the patient - the information obtained allows for avoiding severe allergic reactions to food and other allergens. Molecular analysis helps differentiate between high- and low-risk sensitization.
  6. Molecular information on cross-reactivity - a high level of total IgE does not provide insight into specific sensitization. Specific antibodies produced against different allergens indicate that the individual has been in contact with a particular allergen, with values above 0.3 kU/L considered positive for that allergen. ALEX3® provides extensive molecular information, enabling accurate differentiation between primary allergy and cross-reactive responses. However, a positive result does not always correlate with the clinical presentation. The ALEX3® test should be appointed before or after consultation with an allergist and an IgE total test. This immunoglobulin guides whether an allergic reaction occurs in a person's body so that tests can be performed to determine the exact types of allergies. For the allergological diagnosis to be accurate and precise, it is first of all necessary for the attending physician to obtain accurate information from the patient about the onset of the complaints, their duration, what caused them, their development over time, whether there are other family members with proven allergy or the same symptoms.

ALEX3® is a trademark owned by Macro Array Diagnostics GmbH (MADX)

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