Quality control of the diagnostics for occupational type I allergies

Status:

ongoing

Aims:

There are increasingly considerable deficits in the field of testing tools for occupational allergic diseases. This makes diagnostics, especially in the context of expert opinions, considerably more difficult. These diagnostic gaps are partly due to an increasing reduction of the available test extracts as well as the insufficient quality of the still available text extracts. In order to counteract these diagnostic gaps, a standardization of the diagnostics is therefore indispensable on the one hand, and on the other hand the availability of suitable validated test extracts must be guaranteed. This requires the establishment of quality standards for a demand-oriented production of allergen extracts and the assurance of their availability (Type I allergens).

The aim of the research project is the standardization, continuous documentation and quality assurance as well as the availability of allergy tests for occupational Type I allergies in order to guarantee a meaningful diagnosis for each individual affected insured person with suspected occupational allergy.

Since the proof of sensitization by means of suitable skin tests is an essential component in the chain of assessment of an occupational disease induced by allergens and is also of importance in the established “dermatologist´s procedure (Hautarztverfahren)”, the availability of quality-assured test substances is a prerequisite for a target-oriented care (incl. skin testing). The availability of quality-assured test substances is a prerequisite for target-oriented care (incl. assessment) and therefore of great relevance for all German statutory accident insurance institutions, taking into account the importance of allergological tests, e.g. for prevention, medical and occupational rehabilitation as well as for the classification of the reduction of earning capacity (MdE).

Activities/Methods:

In the field of occupational type I allergies, PEI and IPA will collaborate to determine the requirements for the allergen extracts required for skin prick testing and provocation tests. Subsequently, in cooperation between PEI and IPA, appropriate quality standards will be established for the professionally relevant test allergens identified, leading to the production of sensitive and specific test solutions.

For Type I allergies to workplace allergens, appropriate quality standards will be established, which will allow the production of sensitive and specific test solutions on a pharmacy scale.

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