CORE--METHODS DEVELOMENT LABORATORY

在我中心内建立方法开发核心实验室 是最经济、最高效、最优质的方式 发展努力。经过验证的用于测试的实用测试 正常人和不孕不育患者对持续的支持至关重要 临床和实验室研究的目标是 准确界定一个地区的规范生理学；区分新的 病理生理异常；并设计合理的治疗方法。这个 本方法开发核心的战略目标是：a)开发新的 对中心调查人员有用的试剂和分析方法 个人研究项目；b)进行生化和 这些检测的生理学验证；以及c)转移已证实的检测 到高质量、大容量的核心以实现性能。因此，这些方法 开发核心在翻译过程中起着关键作用 在早期的调查发现和成本效益之间 集中临床实验室检测的性能；本质上是为了 便于将U54研究进展转移到床边。 鉴于该中心目前关注的是人类的FSH调节，我们的 目前的方法开发将首先应用于 提供10种新的蛋白质临床检测方法 包括抑制素/激活素/卵泡抑素系统。使用组合 已经产生的全分子单抗以及 针对所选表位的序列特异性抗体 将利用结构分析来获得特异性双抗体 对这类密切相关的抗原进行双位点分析。这些化验结果将是 设计和验证用于测量血清、卵泡中的这些蛋白质 液体培养和原代细胞培养。与Center密切合作 调查人员，这些化验的有效性将得到检验和规范 建立的数据库对执行《公约》的具体目标至关重要 个人研究项目。随后，将进行这些化验 可供协作中心的调查人员使用 合作研究计划和其他由NICHD资助的研究人员。

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.