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?

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• 作者：Bertr ; Poirier ; Pascale Variot ; Pauline Delourme ; Jacques Maurin ; Sylvie Morgeaux
• 关键词：Hepatitis A vaccine control ; In vivo potency assay ; ELISA ; Correlation ; 3R's ; Alternative method ; Replace ; Statistics
• 刊名：Vaccine
• 出版年：2010
• 出版时间：17 February 2010
• 年：2010
• 卷：28
• 期：7
• 页码：1796-1802
• 全文大小：441 K

文摘

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.