Optimisation and standardisation of skin test solutions for relevant occupational allergens and long-term assurance of validated test extracts. This should maintain and improve diagnostic reliability for medical decisions, preventive measures and research.
Occupational allergies pose a serious health risk for many employees. IgE-mediated immediate-type allergies can affect the respiratory tract and skin, cause severe symptoms and impair occupational activity. Reliable diagnostics are therefore important – both in dermatological procedures (Hautarztverfahren) and in occupational disease assessment procedures, as well as in occupational (individual) prevention and in scientific epidemiological studies to determine the prevalence of occupational allergies. The skin prick test is the central diagnostic tool: it is quick to perform, inexpensive and, when carried out using a standardised procedure with tested extracts, highly sensitive. In combination with an occupational history, it enables the detection of sensitisation and the assessment of a possible causal link between workplace exposure and allergic symptoms. However, the significance of the skin prick test depends largely on the quality and standardisation of the allergen extracts. Differences in production and composition have a considerable influence on the test result. Test solutions for occupational allergens must therefore be optimised, standardised and remain available.
In the IPA-211-AllQuali study, the practical test will now evaluate the standard operating procedures (SOPs) from the previous cooperation project (IPA-164 Berufsderma) with the Paul Ehrlich Institute (PEI) in public pharmacies. The PEI will continue to provide support with regard to legal and regulatory aspects.
The validation of the newly manufactured allergen test solutions for typical occupational allergen sources, including flours, enzymes, storage mites, woods, moulds, animal epithelia, natural latex, fish and seafood, will be carried out in a multicentre in vivo skin test study led by the IPA and supplemented by laboratory tests (in vitro tests) to determine specific IgE concentrations. The aim is to develop quality-assured, standardised and long-term test solutions for occupational allergens.
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Jost R., Kespohl S., Paulus-Tremel K. E., Zimmer J., Bonertz A., Sander I., Klose T., Altin L.-M., Heller S., Heimke-Brinck R., Dörje F., Philippus S., Meyer M., Segebrecht S., Wessel T., Starke D., Schülke S., Raulf M., Mahler V. Possible manufacture of test allergens in public pharmacies for the diagnosis of type I allergies: Legal aspects. Allergologie select. 2024; 8: 251–264.
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Zimmer J., Mahler V. Regulatory framework for development and marketing authorization of allergen products for diagnosis of rare type I and type IV allergies: The current status. Allergologie select. 2024; 8: 212–219.