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2. Validation of ELISA methods for quantification of the major birch allergen Bet v 1 (BSP090)

Author

Kaul, S., Zimmer, J., Dehus, O., Constanzo, A., Daas, A., Buchheit, K. -H, Asturias, J., Arilla, M. C., Barber, D., Bertocchi, A., Brunetto, B., Carnes, J. A., Chapman, M., Chaudemanche, G., Dayan-Kenigsberg, J., Döring, S., Führer, F., Gallego, M. T., Iacovacci, P., Hanschmann, K. M., Holzhauser, T., Hrabina, M., Ledesma, A., Moingeon, P., Nony, E., Pini, C., Plunkett, G., Raulf, M., Reese, G., Sandberg, E., Ingrid Sander, Smith, B., Strecker, D., Valerio, C., Ree, R., Weber, B., and Vieths, S.

Subjects
Europe, Quality Control, Biological Products, Humans, Reproducibility of Results, Enzyme-Linked Immunosorbent Assay, Allergens, Antigens, Plant, Reference Standards, Plant Proteins
Abstract

To date, the potency of allergen products in Europe is expressed in manufacturer-specific units relative to a product-specific in-house reference. Consequently, cross-product comparability of allergen products from different manufacturers with respect to strength and efficacy is impossible. The Biological Standardisation Programme (BSP) project BSP090 addresses this issue via the establishment of reference standards in conjunction with ELISA methods for the quantification of major allergens in allergen products. Since the initiation of BSP090, the recombinant major allergen Bet v 1 has been adopted by the European Pharmacopoeia Commission as a Chemical Reference Substance (CRS). In parallel, two sandwich ELISA systems for quantification of Bet v 1 were found suitable in preliminary phases of BSP090 to be validated in a large collaborative study. In this study, the candidate ELISA systems were compared with respect to accuracy, precision and variability. Thirteen participating laboratories tested model samples containing the CRS as well as spiked and unspiked birch pollen extracts. Both in pre-testing and in the collaborative study, the 2 candidate ELISA systems confirmed their suitability to quantify recombinant and native Bet v 1. As no clear-cut decision for one of the ELISA systems could be made based on the results of the collaborative study, a post-study testing was performed. Bet v 1 content of 30 birch pollen allergen products was determined in parallel in both ELISA systems. Consequently, 1 candidate ELISA system was selected to be proposed as the future European Pharmacopoeia standard method for Bet v 1 quantification.

3. Validation of ELISA methods for quantification of the major birch allergen Bet v 1 (BSP090).

Author

Kaul S, Zimmer J, Dehus O, Constanzo A, Daas A, Buchheit KH, Asturias J, Arilla MC, Barber D, Bertocchi A, Brunetto B, Carnes JA, Chapman M, Chaudemanche G, Dayan-Kenigsberg J, Döring S, Führer F, Gallego MT, Iacovacci P, Hanschmann KM, Holzhauser T, Hrabina M, Ledesma A, Moingeon P, Nony E, Pini C, Plunkett G, Raulf M, Reese G, Sandberg E, Sander I, Smith B, Strecker D, Valerio C, van Ree R, Weber B, and Vieths S

Subjects
Allergens immunology, Antigens, Plant immunology, Biological Products immunology, Biological Products standards, Europe, Humans, Plant Proteins immunology, Plant Proteins standards, Quality Control, Reference Standards, Reproducibility of Results, Allergens analysis, Antigens, Plant analysis, Biological Products analysis, Enzyme-Linked Immunosorbent Assay standards, Plant Proteins analysis
Abstract

To date, the potency of allergen products in Europe is expressed in manufacturer-specific units relative to a product-specific in-house reference. Consequently, cross-product comparability of allergen products from different manufacturers with respect to strength and efficacy is impossible. The Biological Standardisation Programme (BSP) project BSP090 addresses this issue via the establishment of reference standards in conjunction with ELISA methods for the quantification of major allergens in allergen products. Since the initiation of BSP090, the recombinant major allergen Bet v 1 has been adopted by the European Pharmacopoeia Commission as a Chemical Reference Substance (CRS). In parallel, two sandwich ELISA systems for quantification of Bet v 1 were found suitable in preliminary phases of BSP090 to be validated in a large collaborative study. In this study, the candidate ELISA systems were compared with respect to accuracy, precision and variability. Thirteen participating laboratories tested model samples containing the CRS as well as spiked and unspiked birch pollen extracts. Both in pre-testing and in the collaborative study, the 2 candidate ELISA systems confirmed their suitability to quantify recombinant and native Bet v 1. As no clear-cut decision for one of the ELISA systems could be made based on the results of the collaborative study, a post-study testing was performed. Bet v 1 content of 30 birch pollen allergen products was determined in parallel in both ELISA systems. Consequently, 1 candidate ELISA system was selected to be proposed as the future European Pharmacopoeia standard method for Bet v 1 quantification.

Published
2017

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