Poirier Bertrand, Leparc-Goffart Isabelle, Crance Jean-Marc, Fleury Hervé, Garin Daniel, Gut Jean-Pierre, Tissier Marie-Hélène, Fuchs Florence
Agence Française de Sécurité Sanitaire des Produits de Santé, 321 Avenue Jean Jaurès, 69007 Lyon, France.
Biologicals. 2005 Dec;33(4):277-82. doi: 10.1016/j.biologicals.2005.06.006. Epub 2005 Sep 21.
A Proficiency Testing Study (PTS) was organized in France by the French Health Products Safety Agency (Afssaps) aiming at assessing the performance of laboratories in performing a neutralizing anti-vaccinia antibodies titration method by plaque reduction neutralization test (PRNT). The ultimate goal was to establish a national network of qualified and validated laboratories. Five laboratories were included in the PTS and four submitted their data. Three samples of human sera containing various immunoglobulin concentrations (a "high" serum: s-576, a "medium" serum: Ref-19584 and a "low" serum: s-483) were tested by PRNT as described in a procedure supplied by Afssaps and developed in each laboratory during preliminary assays. Data were sent to Afssaps which performed the statistical analysis. The overall performance of the four participating laboratories was satisfactory. This allowed the four participating laboratories to be validated and then to be qualified by the Ministry of Health. Finally a national network for anti-vaccinia immunoglobulins titration was established.
法国卫生产品安全局（Afssaps）在法国组织了一项能力验证研究（PTS），旨在评估各实验室采用蚀斑减少中和试验（PRNT）进行抗牛痘抗体中和滴定方法的性能。最终目标是建立一个经资质认定和验证的全国性实验室网络。该能力验证研究纳入了五个实验室，其中四个提交了数据。按照Afssaps提供并在各实验室初步检测过程中制定的程序，采用PRNT对三份含有不同免疫球蛋白浓度的人血清样本（一份“高浓度”血清：s - 576、一份“中等浓度”血清：Ref - 19584和一份“低浓度”血清：s - 483）进行了检测。数据被发送至Afssaps，由其进行统计分析。四个参与实验室的整体表现令人满意。这使得这四个参与实验室得到了验证，并随后获得了卫生部的资质认定。最终建立了一个抗牛痘免疫球蛋白滴定的全国性网络。
