STANDARDIZATION OF POTENCY TEST METHODS FOR IPV-WHO STUDY

IPV-WHO 研究效力测试方法的标准化

• 批准号: 3748142
• 负责人: R E LUNDQUIST
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3748142
• 关键词: antiviral antibody; attenuated microorganism; cooperative study; diagnosis quality /standard; drug quality /standard; enzyme linked immunosorbent assay; genetic strain; laboratory mouse; lyophilization; monoclonal antibody; nonhuman therapy evaluation; poliomyelitis vaccine; poliovirus; reagent /indicator; virus antigen

The current tests for inactivated poliovirus vaccine (IPV) potency need standardization between laboratories. A collaborative study has been initiated to assess the suitability of candidate reference materials, assess the suitability of different ELISA methods for D determination, and to assess the variability of a standard ELISA method in different laboratories, using the same reagents and coded samples. The materials included in this study are two commercially prepared candidate reference materials; the primary reference PU78-02 currently used by several laboratories, vaccines from different manufacturers shown to be immunogenic in humans; IPV produced from Sabin strains and vaccines of poor in vivo potency. The study will be divided into two phases. The first phase which has been completed, looked at in vitro assays (the second phase will look at in vivo assays). An ELISA developed at CBER using as detection antibodies monoclonal antibodies specific for D antigen is the candidate standard method. We filled and lyophilized our in-house reagents for distribution to collaborators. Several tests were performed to validate the lyophilized reagents prior to mailing. We prepared a detailed SOP which included the dilution schemes for both practice antigens and test antigens. The collaborators have received an ELISA kit containing plates, polyclonal and monoclonal antibodies and monotypic antigen of all three poliovirus types for practice together with the SOPs and the results of our tests using the monotypic antigens. The test antigens labeled A-F were mailed at a later date. Test results have been compiled in a draft form and are being evaluated. We plan to propose using Balb/c mice as a candidate standard in vivo potency method for the second phase of this collaborative study. We will be involved in the analysis and reporting of the study at each phase.

目前灭活脊髓灰质炎病毒疫苗（IPV）效力的测试需要 实验室之间的标准化。 一项合作研究已 开始评估候选参考材料的适用性， 评估不同 ELISA 方法对 D 测定的适用性， 并评估标准 ELISA 方法在不同环境中的变异性 实验室，使用相同的试剂和编码样本。 材料 本研究包括两个商业准备的候选参考 材料;主要参考 PU78-02 目前被几个人使用 实验室显示，来自不同制造商的疫苗 人类具有免疫原性；由 Sabin 毒株和疫苗生产的 IPV 体内效力较差。 该研究将分为两个阶段。 这 第一阶段已经完成，研究了体外测定（ 第二阶段将着眼于体内测定）。 CBER 开发的 ELISA 使用D特异性单克隆抗体作为检测抗体 抗原是候选标准方法。 我们填充并冻干我们的 内部试剂分发给合作者。 进行了多项测试 在邮寄前进行验证冻干试剂。 我们 准备了详细的 SOP，其中包括两者的稀释方案 练习抗原和测试抗原。 合作者已获得 含有板、多克隆和单克隆抗体的 ELISA 试剂盒以及 所有三种脊髓灰质炎病毒类型的单型抗原可一起练习 与 SOP 和我们使用单型抗原的测试结果。 标记为 A-F 的测试抗原稍后邮寄。 测试结果 已编制成草案并正在评估中。 我们计划 建议使用 Balb/c 小鼠作为体内效力方法的候选标准 该合作研究的第二阶段。 我们将参与其中 在每个阶段的研究分析和报告中。