CORE--METHODS DEVELOMENT LABORATORY

在中心内建立方法开发核心实验室 是最经济、高效、优质的方式来巩固我们的 发展努力。经过验证的检测试剂盒，已证明可用于测试 正常人和不孕症患者的持续支持至关重要， 临床和实验室研究，其目标是 精确地定义一个领域的规范生理学;区分新的 病理生理异常;并设计合理的治疗方法。的 该方法开发核心的战略目标是：a）开发新的 对中心研究者有用的试剂和测定， 个人研究项目; B）进行生物化学和 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、高容量的内核，以提高性能。因此，方法 开发核心在转换过程中起着关键作用 早期的调查发现和 集中临床实验室检测的性能;本质上， 促进U 54研究进展从实验室到床边的转移。 鉴于该中心目前的重点是FSH调节在人类，我们的 目前的方法开发将首先承担 提供10种新的蛋白质临床测量方法 包括卵泡抑素/激活素/卵泡抑素系统。使用组合 已经产生的全分子单克隆抗体， 针对所选表位的序列特异性抗体， 结构分析将用于获得特异性双抗体 2-对这些密切相关的抗原进行现场测定。这些试验将 设计并验证用于测量血清、卵泡 液体和原代细胞培养物。与中心密切合作 研究者将对这些试验的有效性进行检测， 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，将进行这些测定， 提供给合作中心的研究人员， 合作研究计划和其他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.