Standardisation of allergen products: 4. Validation of a Candidate European Pharmacopoeia Standard Method for Quantification of Major Grass Pollen Allergen Phl p 5

  1. Zimmer, Julia ORCID logo
  2. Schmidt, Sandra
  3. Kaul, Susanne
  4. Costanzo, Angèle ORCID logo
  5. Buchheit, Karl-Heinz ORCID logo
  6. Brown, Shannon
  7. Carnés, Jerónimo
  8. Chapman, Martin
  9. Chen, Aaron
  10. Neergaard, Michalade de
  11. Döring, Sascha
  12. Hindley, James
  13. Holzhauser, Thomas ORCID logo
  14. Jorajuria, Syvlie
  15. Le Tallec, David
  16. Lombardero, Manuel ORCID logo
  17. Iacovacci, Patrizia ORCID logo
  18. Reese, Gerald
  19. Sander, Ingrid ORCID logo
  20. Smith, Bryan
  21. Strecker, Daniel
  22. van Ree, Ronald ORCID logo
  23. Zebina, Myriam
  24. Vieths, Stefan

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1000 Titel
  • Standardisation of allergen products: 4. Validation of a Candidate European Pharmacopoeia Standard Method for Quantification of Major Grass Pollen Allergen Phl p 5
1000 Autor/in
  1. Zimmer, Julia |
  2. Schmidt, Sandra |
  3. Kaul, Susanne |
  4. Costanzo, Angèle |
  5. Buchheit, Karl-Heinz |
  6. Brown, Shannon |
  7. Carnés, Jerónimo |
  8. Chapman, Martin |
  9. Chen, Aaron |
  10. Neergaard, Michalade de |
  11. Döring, Sascha |
  12. Hindley, James |
  13. Holzhauser, Thomas |
  14. Jorajuria, Syvlie |
  15. Le Tallec, David |
  16. Lombardero, Manuel |
  17. Iacovacci, Patrizia |
  18. Reese, Gerald |
  19. Sander, Ingrid |
  20. Smith, Bryan |
  21. Strecker, Daniel |
  22. van Ree, Ronald |
  23. Zebina, Myriam |
  24. Vieths, Stefan |
1000 Erscheinungsjahr 2021
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2021-07-09
1000 Erschienen in
1000 Quellenangabe
  • 77(2):633-642
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2021
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1111/all.15003 |
1000 Ergänzendes Material
  • https://onlinelibrary.wiley.com/doi/10.1111/all.15003#support-information-section |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • BACKGROUND: The aim of the BSP090 project is the establishment of European Pharmacopoeia Chemical Reference Substances (CRSs) in combination with corresponding standard ELISA methods for quantification of major allergens in allergen products. Here, we present data of a Phl p 5-specific sandwich ELISA that proved suitable for the quantification of Phl p 5, one of the major Timothy grass (Phleum pratense) pollen allergens. METHODS: A Phl p 5-specific ELISA system was assessed with respect to accuracy, precision, inter-assay (within laboratory) and inter-laboratory variations, in a ring trial including 14 laboratories in Europe and the USA. Model samples containing recombinant Phl p 5a CRS as well as native grass pollen extracts were analysed. Each participant was instructed to perform at least one preliminary assay to familiarise with the protocol, followed by three independent assays. RESULTS: The candidate standard ELISA proved suitable to quantify recombinant and native Phl p 5 with satisfactory precision (93% of results within ±30% acceptance range). Inter-assay variation (max. GCV 24%) and especially inter-laboratory variation (max. GCV 13%) showed conclusive results. When assessing accuracy by means of recovery of recombinant spikes from a grass pollen extract matrix, similarly satisfactory spike recovery results were observed for the two spikes with higher concentrations (all within ±30% acceptance range), whereas recovery of the lowest concentration spike was slightly poorer with mean results of six laboratories exceeding acceptance range. CONCLUSIONS: Based on the collaborative study results, the assessed Phl p 5-specific immunoassay is appropriate to be proposed as European Pharmacopoeia standard method.
1000 Sacherschließung
lokal major allergen
lokal Phl p 5
lokal Biological Standardisation Programme
lokal ELISA
lokal Timothy grass
lokal Pollenallergie
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0002-1258-6446|https://frl.publisso.de/adhoc/uri/U2NobWlkdCwgU2FuZHJh|https://frl.publisso.de/adhoc/uri/S2F1bCwgU3VzYW5uZQ==|https://orcid.org/0000-0002-4345-3435|https://orcid.org/0000-0002-8758-0444|https://frl.publisso.de/adhoc/uri/QnJvd24sIFNoYW5ub24g|https://frl.publisso.de/adhoc/uri/Q2FybsOpcywgSmVyw7NuaW1vIA==|https://frl.publisso.de/adhoc/uri/Q2hhcG1hbiwgTWFydGluIA==|https://frl.publisso.de/adhoc/uri/Q2hlbiwgQWFyb24g|https://frl.publisso.de/adhoc/uri/TmVlcmdhYXJkLCBNaWNoYWxhZGUgZGUg|https://frl.publisso.de/adhoc/uri/RMO2cmluZywgU2FzY2hhICA=|https://frl.publisso.de/adhoc/uri/SGluZGxleSwgSmFtZXMgICAgICAg|https://orcid.org/0000-0002-7818-7261|https://frl.publisso.de/adhoc/uri/Sm9yYWp1cmlhLCBTeXZsaWUgICAgICA=|https://frl.publisso.de/adhoc/uri/TGUgVGFsbGVjLCBEYXZpZCAgIA==|https://orcid.org/0000-0001-5386-5321|https://orcid.org/0000-0001-9133-5153|https://frl.publisso.de/adhoc/uri/IFJlZXNlLCBHZXJhbGQgIA==|https://orcid.org/0000-0002-5014-4112|https://frl.publisso.de/adhoc/uri/U21pdGgsIEJyeWFuICAgIA==|https://frl.publisso.de/adhoc/uri/U3RyZWNrZXIsIERhbmllbCA=|https://orcid.org/0000-0003-0767-0894|https://frl.publisso.de/adhoc/uri/WmViaW5hLCBNeXJpYW0gICAgIA==|https://d-nb.info/gnd/143949705
1000 Label
1000 Förderer
  1. European Directorate for the Quality of Medicines & HealthCare (EDQM) |
1000 Fördernummer
  1. BSP090
1000 Förderprogramm
  1. -
1000 Dateien
1000 Förderung
  1. 1000 joinedFunding-child
    1000 Förderer European Directorate for the Quality of Medicines & HealthCare (EDQM) |
    1000 Förderprogramm -
    1000 Fördernummer BSP090
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6432336.rdf
1000 Erstellt am 2022-03-17T11:47:21.681+0100
1000 Erstellt von 323
1000 beschreibt frl:6432336
1000 Bearbeitet von 317
1000 Zuletzt bearbeitet Wed May 04 09:20:23 CEST 2022
1000 Objekt bearb. Wed May 04 09:19:48 CEST 2022
1000 Vgl. frl:6432336
1000 Oai Id
  1. oai:frl.publisso.de:frl:6432336 |
1000 Sichtbarkeit Metadaten public
1000 Sichtbarkeit Daten public
1000 Gegenstand von

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