The CREATE Project:: development of certified reference materials for allergenic products and validation of methods for their quantification

被引：146

作者：

Van Ree, R. ^{[1
]}

Chapman, M. D. ^{[1
]}

Ferreira, F. ^{[2
]}

Vieths, S. ^{[3
]}

Bryan, D. ^{[4
]}

Cromwell, O. ^{[5
]}

Villalba, M. ^{[6
]}

Durham, S. R. ^{[7
]}

Becker, W. M. ^{[8
]}

Aalbers, M. ^{[9
]}

André, C. ^{[10
]}

Barber, D. ^{[11
]}

Bahima, A. Cistero ^{[12
]}

Custovic, A. ^{[13
]}

Didierlaurent, A. ^{[10
]}

Dolman, C. ^{[4
]}

Dorpema, J. W. ^{[14
]}

Di Felice, G. ^{[15
]}

Eberhardt, F.

Fernandez Caldas, E. ^{[16
]}

Fernandez Rivas, M. ^{[17
]}

Fiebig, H. ^{[5
]}

Focke, M. ^{[18
]}

Foetisch, K. ^{[3
]}

Gadermaier, G. ^{[2
]}

Das, R. G. ^{[4
]}

Gonzalez Mancebo, E. ^{[19
]}

Himly, M. ^{[2
]}

Kinaciyan, T. ^{[18
]}

Knulst, A. C. ^{[20
]}

Kroon, A. M. ^{[21
]}

Lepp, U. ^{[8
]}

Marco, F. M. ^{[22
]}

Mari, A. ^{[23
]}

Moingeon, P. ^{[10
]}

Monsalve, R. ^{[11
]}

Neubauer, A. ^{[24
]}

Notten, S. ^{[9
]}

Heer, P. Ooievaarde ^{[9
]}

Pauli, G. ^{[25
]}

Pini, C. ^{[15
]}

Purohit, A. ^{[25
]}

Quiralte, J. ^{[26
]}

Rak, S. ^{[27
]}

Raulf-Heimsoth, M. ^{[28
]}

SanMiguel Moncin, M. M. ^{[12
]}

Simpson, B. ^{[13
]}

Tsay, A. ^{[1
]}

Vailes, L. ^{[1
]}

Wallner, M. ^{[2
]}

机构：

[1] Indoor Biotechnol, Charlottesville, VA USA

[2] Salzburg Univ, A-5020 Salzburg, Austria

[3] Paul Ehrlich Inst, D-6070 Langen, Germany

[4] NIBSC, Potters Bar, Herts, England

[5] Allergopharma, Reinbek, Germany

[6] Univ Complutense, E-28040 Madrid, Spain

[7] Imperial Coll, London, England

[8] Res Ctr, Borstel, Germany

[9] Sanquin, Amsterdam, Netherlands

[10] Stallergenes SA, Antony, France

[11] ALK Abello, Madrid, Spain

[12] Univ Inst Dexeus, Barcelona, Spain

[13] Univ Manchester, Manchester, Lancs, England

[14] HAL Allergy BV, Haarlem, Netherlands

[15] Ist Super Sanita, I-00161 Rome, Italy

[16] CBF Leti SA, Madrid, Spain

[17] Hosp Clin San Carlos, Madrid, Spain

[18] Med Univ Vienna, Vienna, Austria

[19] Hosp Ramon & Cajal, E-28034 Madrid, Spain

[20] Univ Med Ctr Utrecht, Utrecht, Netherlands

[21] European Allergen Manufacturers Grp, Haarlem, Netherlands

[22] ASAC Pharmaceut Int SA, Alicante, Spain

[23] IRCCS, IDI, CACeS, Rome, Italy

[24] Biomay AG, Vienna, Austria

[25] Univ Hosp, Strasbourg, France

[26] Complejo Hosp Jaen, Jaen, Spain

[27] Sahlgrens Univ Hosp, Gothenburg, Sweden

[28] Ruhr Univ Bochum, BGFA, D-4630 Bochum, Germany

来源：

ALLERGY | 2008年 / 63卷 / 03期

基金：

英国医学研究理事会;

关键词：

D O I：

10.1111/j.1398-9995.2007.01612.x

中图分类号：

R392 [医学免疫学];

学科分类号：

100102 ;

摘要：

Allergen extracts have been used for diagnosis and treatment of allergy for around 100 years. During the second half of 20th century, the notion increasingly gained foothold that accurate standardization of such extracts is of great importance for improvement of their quality. As a consequence, manufacturers have implemented extensive protocols for standardization and quality control. These protocols have overall IgE-binding potencies as their focus. Unfortunately, each company is using their own in-house reference materials and their own unique units to express potencies. This does not facilitate comparison of different products. During the last decades, most major allergens of relevant allergen sources have been identified and it has been established that effective immunotherapy requires certain minimum quantities of these allergens to be present in the administered maintenance dose. Therefore, the idea developed to introduce major allergens measurements into standardization protocols. Such protocols based on mass units of major allergen, quantify the active ingredients of the treatment and will at the same time allow comparison of competitor products. In 2001, an EU funded project, the CREATE project, was started to support introduction of major allergen based standardization. The aim of the project was to evaluate the use of recombinant allergens as reference materials and of ELISA assays for major allergen measurements. This paper gives an overview of the achievements of the CREATE project.

引用

页码：310 / 326

页数：17

共 44 条

[11] A COLLABORATIVE STUDY ON THE 1ST INTERNATIONAL STANDARD OF DERMATOPHAGOIDES-PTERONYSSINUS (HOUSE DUST MITE) EXTRACT [J].