In-vivo diagnostic test allergens in Europe: A call to action and proposal for recovery plan-An EAACI position paper

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In-vivo diagnostic test allergens in Europe : A call to action and proposal for recovery plan-An EAACI position paper

Klimek, Ludger (författare): Ctr Rhinol & Allergol, Quellen 10, D-65183 Wiesbaden, Germany.

Hoffmann, Hans J. (författare): Aarhus Univ, Dept Clin Med, Aarhus C, Denmark.

Kalpaklioglu, Ayse F. (författare): Kirikkale Univ, Dept Pulm & Allerg Dis, Fac Med, Kirikkale, Turkey.

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Demoly, Pascal (författare): Univ Hosp Montpellier, Dept Resp Med, Montpellier, France.;Sorbonne Univ, Equipe EPAR, IPLESP, UMR S 1136, Paris, France.

Agache, Ioana (författare): Transylvania Univ Brasov, Dept Allergy & Clin Immunol, Fac Med, Brasov, Romania.

Popov, Todor A. (författare): Univ Hosp Sv Ivan Rilski, Sofia, Bulgaria.

Muraro, Antonella (författare): Padua Gen Univ Hosp, European Acad Allergy & Clin Immunol EAACI, Head Food Allergy Referral Ctr Veneto Reg, Ctr Paediat & Child Hlth,Dept Women & Child Hlth, Padua, Italy.

Schmid-Grendelmeier, Peter (författare): Univ Zurich, Dept Dermatol, Allergy Unit, Zurich, Switzerland.

Bonini, Sergio (författare): Italian Natl Res Council, Inst Translat Pharmacol, Rome, Italy.

Bonertz, Andreas (författare): Paul Ehrlich Inst, Langen, Germany.

Mahler, Vera (författare): Paul Ehrlich Inst, Langen, Germany.

Vieths, Stefan (författare): Paul Ehrlich Inst, Langen, Germany.

Pfaar, Oliver (författare): Philipps Univ Marburg, Univ Hosp Marburg, Sect Rhinol & Allergy, Dept Otorhinolaryngol Head & Neck Surg, Marburg, Germany.

Zuberbier, Torsten (författare): Charite Univ Med Berlin, Dept Dermatol & Allergy, Allergie Centrum Charite, Berlin, Germany.

Jutel, Marek (författare): Wroclaw Med Univ, European Acad Allergy & Clin Immunol EAACI, Dept Clin Immunol, Wroclaw, Poland.;ALL MED Med Res Inst, Wroclaw, Poland.

Schmidt-Weber, Carsten (författare): Tech Univ, Ctr Allergy & Environm ZAUM, Munich, Germany.;Helmholtz Ctr Munich, Munich, Germany.

Hellings, Peter W. (författare): Euforea, Brussels, Belgium.;Katholieke Univ Leuven, Dept Microbiol & Immunol, Lab Clin Immunol, Leuven, Belgium.

Dreborg, Sten, 1933- (författare): Uppsala universitet,Institutionen för kvinnors och barns hälsa

Bonini, Matteo (författare): Univ Cattolica Sacro Cuore, Fdn Policlin Univ A Gemelli IRCCS, Dept Cardiovasc & Thorac Sci, Rome, Italy.;Imperial Coll London, Natl Heart & Lung Inst, London, England.

Brough, Helen A. (författare): Guys & St Thomas Hosp NHS Fdn Trust, European Acad Allergy & Clin Immunol EAACI, Paediat Sect, London, England.;Guys & St Thomas Hosp NHS Fdn Trust, Evelina Childrens Hosp, Serv Childrens Allergy Serv, London, England.;Kings Coll London, St Thomas Hosp, Dept Women & Childrens Hlth, Paediat Allergy Grp, London, England.;Kings Coll London, Sch Immunol & Microbial Sci, Peter Gorer Dept Immunobiol, Paediat Allergy Grp,Guys Hosp, London, England.

Bousquet, Jean (författare): European Innovat Partnership Active & Healthy Age, MACVIA France, Malad Chron VieillissementActifen France, Montpellier, France.;Univ Montpellier, Montpellier, France.;Charite Univ Med Berlin, Humboldt Univ Berlin, Dept Dermatol & Allergy, Comprehens Allergy Ctr,Berlin Inst Hlth, Berlin, Germany.

Hoffmann-Sommergruber, Karin (författare): Med Univ Vienna, Dept Pathophysiol & Allergy Res, Vienna, Austria.

Palomares, Oscar (författare): Univ Complutense Madrid, Dept Biochem & Mol Biol, Madrid, Spain.

Ollert, Markus (författare): Luxembourg Inst Hlth, Dept Infect & Immun, Esch Sur Alzette, Luxembourg.;Univ Southern Denmark, Dept Dermatol, Odense Res Ctr Anaphylaxis, Odense C, Denmark.;Univ Southern Denmark, Allergy Ctr, Odense Res Ctr Anaphylaxis, Odense C, Denmark.

Shamji, Mohamed H. (författare): Imperial Coll London, Natl Heart & Lung Inst, Asthma UK Ctr Allerg Mech Asthma, London, England.

Cardona, Victoria (författare): Hosp Valle De Hebron, Allergy Sect, Dept Internal Med, Barcelona, Spain.;ARADyAL Res Network, Caceres, Spain.

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Ctr Rhinol & Allergol, Quellen 10, D-65183 Wiesbaden, Germany Aarhus Univ, Dept Clin Med, Aarhus C, Denmark. (creator_code:org_t)

2020-09-14
2020
Engelska.
Ingår i: Allergy. European Journal of Allergy and Clinical Immunology. - : Wiley. - 0105-4538 .- 1398-9995. ; 75:9, s. 2161-2169

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Tidskriftsartikel (refereegranskat)

Abstract Ämnesord

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Diagnostic allergens are defined as medicinal products in the EU. Marketing authorization by national authorities is necessary; however, diagnostic allergens are not homogeneously regulated in different EU member states. Allergen manufacturers argue with increasing costs forcing them to continuously reduce the diagnostic allergen portfolios offered to allergists. In contrast, EAACI and national European Allergy Societies see the need for the availability of a wide range of high‐quality diagnostic allergens for in vivo diagnosis of IgE‐mediated allergies not only covering predominant but also less frequent allergen sources. In a recent EAACI task force survey, the current practice of allergy diagnosis was shown to rely on skin tests as first option in almost 2/3 of all types of allergic diseases and in 90% regarding respiratory allergies.With the need to ensure the availability of high‐quality diagnostic allergens in the EU, an action plan has been set up by EAACI to analyse the current regulatory demands in EU member states and to define possible solutions stated in this document: (a) simplification of authorization for diagnostic allergens; (b) specific regulation of special types of diagnostic allergens; (c) new models beyond the current model of homologous groups; (d) simplification of pharmacovigilance reporting; (e) reduction of regulation fees for diagnostic allergens; (f) reimbursement for diagnostic allergens.Joining forces of allergists, manufacturers and authorities are of high importance to ensure remaining relevant allergens in the EU markets to facilitate a sustainable and comprehensive service for the diagnosis and treatment of allergic diseases.

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In-vivo diagnostic test allergens in Europe : A call to action and proposal for recovery plan-An EAACI position paper

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