VALIDATION PRODUCTS FOR CYSTIC FIBROSIS MOLECULAR TESTS

描述(由申请人提供)：该二期项目开发了一部小说， 一整套分子基质控产品的质量保证 囊性纤维化(诊断试验)。对照与患者一起进行测试 联邦法规要求的标本，以确保医疗质量 测试。分子诊断技术的采用因缺乏 商业质量控制。以病人为基础的材料经常被用作 控制，这带来了患者保密性、感染风险和 供应有限。第一阶段研究证明了创新的 用于生产稳定的、可再生的、非传染性控制的系统。同相 II，构建的结构将包含16个具有重要医学意义的CF基因 携带47个常见的CF诊断突变的片段。独一无二的 用于分段组装的盒式方案将产生易于修改的结构 以适应新的分子测试。该建筑将通过一个 专利技术，悬浮在生物基质中以模拟患者 样本。我们的控制组将验证CF诊断分析，并将用作 为基因测试设计生产质量保证产品的模式系统 来检测多重突变。这些产品的可获得性很重要 为医疗诊断做出了重大贡献，为病人的护理做出了重大贡献 确保基因检测结果的质量。 建议的商业应用：不可用

DESCRIPTION (provided by applicant): This Phase II project develops a novel, comprehensive set of control products for quality assurance of molecular-based cystic fibrosis (OF) diagnostic tests. Controls are tested alongside patient specimens, as required by Federal regulations, to ensure quality in medical testing. Adoption of molecular diagnostics technology is inhibited by lack of commercial quality controls. Patient-based materials are often used as controls, which presents issues of patient confidentiality, infection risk and limited supply. Phase I research demonstrated feasibility of an innovative system for production of stable, renewable, noninfectious controls. In Phase II, constructs will be engineered to contain 16 medically important CF gene segments that carry forty-seven common CF diagnostic mutations. A unique cassette scheme for assembly of segments will yield a construct easily modified to accommodate new molecular tests. The construct will be stabilized by a proprietary technology and suspended in a biological matrix to mimic patient samples. Our control set will validate CF diagnostic assays and will serve as a model system to produce quality assurance products for genetic tests designed to detect multiple mutations. The availability of these products is important to medical diagnostics and makes a significant contribution to patient care by ensuring quality of genetic testing results. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE