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Molecular allergy diagnostic tests: development and relevance in clinical practice.

ABSTRACT: Molecular allergy is based on identification, characterization and subsequent use of single allergens, being components of complex allergen sources like pollen, mites, furred animals, foods or insect venoms. Only few protein families contain relevant allergens of similar sequence and structure, carrying common IgE epitopes as the basis of cross reactivity. Used as purified or recombinant (glyco)proteins single allergens can potentially improve in-vitro diagnostics, particularly allergen-specific IgE assays through a) increased sensitivity, b) use of risk and marker allergens, c) component-resolved diagnostics (CRD). CRD can differentiate primary, species-specific from secondary, cross-reactive sensitizations to single allergens. Allergen components facilitate an increased analytical sensitivity, particularly if they are underrepresented or missing in conventional allergen extracts. They are mainly used in single assays (singleplex) for the detection of IgE, but also in a microarray format (multiplex) with 112 components from 50 allergen sources with slightly decreased analytical sensitivity. Concepts of molecular allergy can only be separately defined and utilized for each allergen source (pollen, mites, foods or insect venoms). As soon as essential singe allergens are available, their specific role in diagnostics should be defined. This requires well characterized patient cohorts from various countries, since exposure, allergic immune response and clinical relevance can vary substantially between individual subjects and geographical regions. The patient's clinical information is essential for proper interpretation of molecular allergology results. The history and/or challenge test results will finally provide evidence, in how far a sensitization to single allergens might be clinically relevant or not.

SUBMITTER: Kleine-Tebbe J

PROVIDER: S-EPMC6040004 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Molecular allergy diagnostic tests: development and relevance in clinical practice.

Kleine-Tebbe J J Jappe U U

Allergologie select 20170804 2

Molecular allergy is based on identification, characterization and subsequent use of single allergens, being components of complex allergen sources like pollen, mites, furred animals, foods or insect venoms. Only few protein families contain relevant allergens of similar sequence and structure, carrying common IgE epitopes as the basis of cross reactivity. Used as purified or recombinant (glyco)proteins single allergens can potentially improve in-vitro diagnostics, particularly allergen-specific ...[more]

PMID: 30402615

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Project description:BackgroundAccurate diagnosis is a fundamental aspect of appropriate healthcare. However, clinicians need guidance when implementing diagnostic tests given the number of tests available and resource constraints in healthcare. Practitioners of health often feel compelled to implement recommendations in guidelines, including recommendations about the use of diagnostic tests. However, the understanding about diagnostic tests by guideline panels and the methodology for developing recommendations is far from completely explored. Therefore, we evaluated the factors that guideline developers and users need to consider for the development of implementable recommendations about diagnostic tests.MethodsUsing a critical analysis of the process, we present the results of a case study using the Grading of Recommendations Applicability, Development and Evaluation (GRADE) approach to develop a clinical practice guideline for the diagnosis of Cow Milk Allergy with the World Allergy Organization.ResultsTo ensure that guideline panels can develop informed recommendations about diagnostic tests, it appears that more emphasis needs to be placed on group processes, including question formulation, defining patient-important outcomes for diagnostic tests, and summarizing evidence. Explicit consideration of concepts of diagnosis from evidence-based medicine, such as pre-test probability and treatment threshold, is required to facilitate the work of a guideline panel and to formulate implementable recommendations.DiscussionThis case study provides useful guidance for guideline developers and clinicians about what they ought to demand from clinical practice guidelines to facilitate implementation and strengthen confidence in recommendations about diagnostic tests. Applying a structured framework like the GRADE approach with its requirement for transparency in the description of the evidence and factors that influence recommendations facilitates laying out the process and decision factors that are required for the development, interpretation, and implementation of recommendations about diagnostic tests.

Dataset Information

Molecular allergy diagnostic tests: development and relevance in clinical practice.

Publications

Molecular allergy diagnostic tests: development and relevance in clinical practice.

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