CORE--METHODS DEVELOMENT LABORATORY

核心--方法开发实验室

• 批准号: 6108660
• 负责人: PATRICK SLUSS
• 金额: $ 28.05万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6108660
• 关键词: biomedical facility; fertility; follicle stimulating hormone; follistatin; hormone regulation /control mechanism; inhibin; method development; monoclonal antibody

Establishment of a Methods Development Core Laboratory within our Center is the most economical, efficient, and quality way to consolidate our development efforts. Validated assays of proven utility for testing normals and patients with infertility are critical to the ongoing support of the clinical and laboratory investigations whose goals are to precisely define the normative physiology in an area; to distinguish new pathophysiologic abnormalities; and to devise rational therapies. The strategic goals of this Methods Development Core are: a) to develop new reagents and assays useful to Center Investigators within their individual research Projects; b) to perform the biochemical and physiologic validation of these assays; and c) to transfer proven tests to high quality, high volume cores for performance. Thus, the Methods Development Core plays a critical role in the translational process between early investigative discoveries and the cost efficient performance of centralized clinical laboratory testing; in essence to facilitate bench to bedside transfer of U54 research progress. Given the Center's current focus on FSH regulation in the human, our current methods development will initially be brought to bear on providing 10 new assays for the clinical measurement of proteins comprising the inhibin/activin/follistatin system. Using a combination of whole molecule monoclonal antibodies already generated as well as sequence-specific antibodies directed at selected epitopes identified by structural analysis will be utilized to achieve specific double antibody 2-site assays for such closely related antigens. These assays will be designed and validated for measuring these proteins in serum, follicular fluid, and primary cell cultures. In close collaboration with Center investigators, the validity of these assays will be tested and normative databases established critical to the execution of the Specific Aims of the individual research projects. Subsequently, these assays will be made available to investigators of the collaborating Center within the Cooperative Research Program and to other NICHD-funded investigators.

在我们中心建立方法开发核心实验室 是巩固我们的最经济，高效和质量的方式 发展工作。经过验证的测试实用程序的测定 不育的正常患者对于持续支持至关重要 临床和实验室调查的目标是 精确定义一个地区的规范生理学；区分新 病理生理异常；并设计理性疗法。这 这种方法开发核心的战略目标是：a）开发新的 试剂和测定对于将调查人员置于其内部 个人研究项目； b）执行生化和 这些测定法的生理验证；和c）转移经过验证的测试 高质量，高量核心以进行性能。因此，方法 开发核心在翻译过程中起着至关重要的作用 在早期的调查发现与成本效益之间 集中式临床实验室测试的性能；本质上 促进长凳到U54研究进度的床边转移。 鉴于该中心目前对人类的FSH调节的关注，我们 当前的方法开发最初将被带来 为蛋白质的临床测量提供10种新测定 包含抑制素/激活素/follistatin系统。使用组合 已经产生的整个分子单克隆抗体以及 针对选定表位的序列特异性抗体， 结构分析将用于实现特定的双抗体 这种密切相关的抗原的2个点测定。这些测定将是 设计和验证用于测量血清中的这些蛋白质 液体和原代细胞培养物。与中心密切合作 研究人员，这些测定的有效性将进行测试和规范性 数据库确定对执行具体目的至关重要 个别研究项目。随后，将进行这些测定 可用于合作中心的调查人员 合作研究计划和其他NICHD资助的研究人员。