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International Bordetella pertussis assay standardization and harmonization meeting report. Centers for Disease Control and Prevention, Atlanta, Georgia, United States, 19-20 July 2007

机译:国际百日咳博德特氏菌测定法标准化和协调会议报告。美国乔治亚州亚特兰大市疾病预防控制中心,2007年7月19日至20日

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An international meeting on Bordetella pertussis assay standardization and harmonization was held at the Centers for Disease Control and Prevention (CDC), Atlanta, GA, 19-20 July 2007. The goal of the meeting was to harmonize the immunoassays used for pertussis diagnostics and vaccine evaluation, as agreed upon by academic and government researchers, regulatory authorities, vaccine manufacturers, and the World Health Organization (WHO). The primary objectives were (1) to provide epidemiologic, laboratory, and statistical background for support of global harmonization; (2) to overview the current status of global epidemiology, pathogenesis and immunology of pertussis; (3) to develop a consensus opinion on existing gaps in understanding standardization of pertussis assays used for serodiagnosis and vaccine evaluation; and (4) to search for a multicenter process for addressing these priority gaps. Presentations and discussions by content experts addressed these objectives. A prioritized list of action items to improve standardization and harmonization of pertussis assays was identified during a group discussion at the end of the meeting. The major items included: (1) to identify a group that will organize, prepare, maintain, and distribute proficiency panels and key reagents such as reference and control sera; (2) to encourage the development and identification of one or more reference laboratories that can serve as an anchor and resource for other laboratories; (3) to define a performance-based assay method that can serve as a reference point for evaluating laboratory differences; (4) to develop guidance on quality of other reagents, e.g., pertussis toxin and other antigens, and methods to demonstrate their suitability; (5) to establish an international working group to harmonize the criteria to evaluate the results obtained on reference and proficiency panel sera; (6) to create an inventory to determine the amount of appropriate and well-characterized sera that are available globally to be used as bridging reagents for vaccine licensure; and (7) to seek specific guidance from regulatory authorities regarding the expectations and requirements for the licensure of new multicomponent pertussis vaccines.
机译:2007年7月19日至20日,在佐治亚州亚特兰大市疾病预防控制中心(CDC)召开了百日咳博德特氏菌测定标准化和协调性国际会议。该会议的目标是统一用于百日咳诊断和疫苗的免疫测定经学术和政府研究人员,监管机构,疫苗制造商和世界卫生组织(WHO)同意进行的评估。主要目标是(1)提供流行病学,实验室和统计背景,以支持全球统一; (2)概述百日咳全球流行病学,发病机理和免疫学的现状; (3)就在理解用于血清诊断和疫苗评估的百日咳试验的标准化方面存在的差距形成共识。 (4)寻找解决这些优先权差距的多中心流程。内容专家的演示和讨论解决了这些目标。在会议结束时的小组讨论中,确定了改善百日咳测定法标准化和统一性的优先事项清单。主要项目包括:(1)确定一个组织,准备,维护和分配熟练专家组和关键试剂(例如参考和对照血清)的小组; (2)鼓励发展和确定一个或多个参考实验室,这些参考实验室可以作为其他实验室的基础和资源; (3)定义基于性能的测定方法,可以作为评估实验室差异的参考点; (4)制定关于其他试剂(例如百日咳毒素和其他抗原)质量的指南,以及证明其适用性的方法; (5)建立一个国际工作组,以统一标准,以评估参考和熟练专家组血清获得的结果; (6)建立一个清单,以确定可在全球范围内用作疫苗许可桥接试剂的适当和特征明确的血清数量; (7)就获得新的多组分百日咳疫苗许可的期望和要求,向监管机构寻求具体指导。

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