DEVELOPMENT OF LIPOSOME COMPLEXED RNA QUALITY CONTROLS

描述：（改编自申请人摘要）：临床管理法规 实验室测试和良好实验室规范要求每个患者测试 伴随着质量控制。当前核酸检测的质控品 通常由重复使用的患者标本组成，这些标本不稳定， 传染性第一阶段项目开发了一个系统， 用于基于分子的诊断测试的控制和标准。独特的产品 其特征如下：在临床试验中核酸的释放， 无感染性，并且在室温和4 ℃下稳定数月。的 合成对照是制备的阳离子脂质体包封的寡核苷酸 使用改良的脂质体基因治疗技术。对于这项可行性研究， 原型产品将是一种基于BCR/abl的RNA片段， 阳离子脂质体在几天的例行检查中获得可重复的结果 对照材料的实验室使用将证明成功。独特的工艺 其特征如下：易于制备，适用于RNA和DNA， 以及包含大小高达19 kb的寡核苷酸的能力。结果 这项工作将是一个低成本的方法，生产稳定，易于 产生包封的RNA和DNA寡核苷酸。一系列控件和 包括定量RNA标准品在内的标准品将在II期开发。 拟定商业应用： 在这个第一阶段项目中开发的技术将用于生产质量控制 用于BCR/abl实验室测试的产品。目标客户将是所有诊断实验室 慢性粒细胞白血病相关的BCR/abl基因重排检测 (CML)和CML诊断试剂盒的制造商。

DESCRIPTION:(adapted from applicant'sabstract): Regulations governing clinical laboratory testing and good laboratory practice require each patient test be accompanied by quality controls. Controls for current nucleic acid testing usually consist of reused patient specimens that are unstable and may be infectious. This Phase I project develops a system to produce synthetic controls and standards for molecular based diagnostic testing. Unique product features are the following: the release of nucleic acid in the clinical test, non-infectivity, and stability for months at room temperature and 4 C. The synthetic controls are cationic liposome-encapsulated oligonucleotides produced using modified liposomal gene therapy techniques. For this feasibility study, the prototype product will be a BCR/abl based RNA segment complexed with a cationic liposome. Reproducible results obtained during several days of routine laboratory use of the control material will demonstrate success. Unique process features are the following: ease of preparation, applicability to RNA and DNA, and the ability to encompass oligonucleotides up to 19 kb in size. The result of this work will be a low cost method for the production of stable and easy to produce encapsulated RNA and DNA oligonucleotides. A family of controls and standards including quantitative RNA standards will be developed in Phase II. PROPOSED COMMERCIAL APPLICATION: The technology developed in this Phase I project will be used to produce quality control products for BCR/abl laboratory tests. Targeted customers will be all diagnostic laboratories testing for the BCR/abl gene rearrangement associated with chronic myelogenous leukemia (CML) and manufacturers of CML diagnostic kits.