title: Diagnostic test allergens used for in vivo diagnosis of allergic diseases are at risk: a European Perspective.
abstract: In the European Union (EU), allergens used for diagnostic tests (TAs) are defined as medicinal products and have to be registered by national authorities. The current situation is not homogeneous. Existing authorizations need to be kept in the market in some EU states, while others need complete new authorizations requiring clinical trials, quality assurance methods, stability studies, and periodic safety update reports. Allergen manufacturers argue that offering a comprehensive panel of TAs may be economically disastrous. Expenses for initiation and maintenance of TA authorizations far exceed their related revenues and manufacturers may be forced to significantly limit their allergen portfolios. The availability of a wide range of high-quality TAs is very important for in vivo diagnoses of IgE-mediated allergies. Increased regulatory demands induce costs that need to be covered by public health organizations or reimbursed by health insurance companies.
authors.affiliation: Center for Rhinology and Allergology, Wiesbaden, Germany.
authors.forename: L
authors.initials: L
authors.lastname: Klimek
authors.affiliation: Interest Group on Allergy Diagnosis, European Academy of Allergy and Clinical Immunology, Aarhus C, Denmark.|Department of Respiratory Diseases and Allergy, Department of Clinical Medicine, Aarhus University, Aarhus C, Denmark.
authors.forename: H J
authors.initials: HJ
authors.lastname: Hoffmann
authors.affiliation: Institute of Laboratory Medicine and Pathobiochemistry, Molecular Diagnostics, Philipps University Marburg, University Hospital Giessen and Marburg GmbH, Marburg, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Renz
authors.affiliation: Department of Respiratory Medicine, University Hospital of Montpellier, France and Sorbonne Universités, UPMC Paris 06, UMR-S 1136, IPLESP, Equipe EPAR, Paris, France.
authors.forename: P
authors.initials: P
authors.lastname: Demoly
authors.affiliation: Department for Dermatology, Allergology and Venerology, Immunodermatology and Experimental Allergology, MHH, Hannover, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Werfel
authors.affiliation: Department of Paediatric Pneumology & Immunology, Charité University Medical Centre, Berlin, Germany.
authors.forename: P M
authors.initials: PM
authors.lastname: Matricardi
authors.affiliation: Secretary General of the European Academy of Allergy and Clinical Immunology (EAACI), Padua General University Hospital, Padua, Italy.|Food Allergy Referral Centre Veneto Region, Department of Women and Child Health, Padua General University Hospital, Padua, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Muraro
authors.affiliation: Allergy Unit, Department for Dermatology, University of Zurich, Zürich, Switzerland.
authors.forename: P
authors.initials: P
authors.lastname: Schmid-Grendelmeier
authors.affiliation: Secretaria de la Fundación SEAIC, Clinical & Translational Allergy, S. Allergologia, S. Medicina Interna, Hospital Vall d'Hebron, Barcelona, Spain.
authors.forename: V
authors.initials: V
authors.lastname: Cardona
authors.affiliation: European Academy of Allergy & Clinical Immunology (EAACI), Centre for Paediatrics and Child Health, Institute of Human Development, University of Manchester, Royal Manchester Children's Hospital, Manchester, UK.
authors.forename: N G
authors.initials: NG
authors.lastname: Papadopoulos
mesh_terms: D000485:Allergens / Q000276:immunology*; D057069:Diagnostic Test Approval / Q000191:economics / Q000331:legislation & jurisprudence / Q000592:standards; D003955:Diagnostic Tests, Routine / Q000379:methods* / Q000592:standards*; D005060:Europe; D006801:Humans; D006967:Hypersensitivity / Q000175:diagnosis* / Q000276:immunology*
chemical_list: D000485:Allergens
keywords: European Pharmacopoeia; bronchial provocation test; conjunctival provocation test; nasal provocation test; skin test allergens