کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2405442 1103034 2010 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Would an in vitro ELISA test be a suitable alternative potency method to the in vivo immunogenicity assay commonly used in the context of international Hepatitis A vaccines batch release?
موضوعات مرتبط
علوم زیستی و بیوفناوری ایمنی شناسی و میکروب شناسی ایمونولوژی
پیش نمایش صفحه اول مقاله
Would an in vitro ELISA test be a suitable alternative potency method to the in vivo immunogenicity assay commonly used in the context of international Hepatitis A vaccines batch release?
چکیده انگلیسی

Since many years Afssaps applies the 3R's strategy (replacement, reduction and refinement) for the use of laboratory animal testing in the framework of vaccine batch release. In this context, for Hepatitis A vaccines, a study was carried out to assess the feasibility of replacing the in vivo “Gold Standard” potency assay by the Afssaps’ validated in-house antigen content in vitro assay on routine testing. The use of a panel of potent vaccine batches and reduced-potency samples by heating demonstrated a correlation between the two methods. This encourages Afssaps to progressively switch from in vivo to in vitro assay in the framework of Hepatitis A vaccines batch release.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Vaccine - Volume 28, Issue 7, 17 February 2010, Pages 1796–1802
نویسندگان
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