CFLP BASED DETERMINATION OF HEPATITIS C VIRUS GENOTYPE

丙型肝炎病毒(丙型肝炎病毒)是一种广泛、持久的疾病，影响着1- 占世界人口的2%。只有一小部分丙型肝炎病毒受到影响 个体对干扰素治疗有反应。病毒基因已经出现了 作为临床上有意义的预测指标，用于确定对 干扰素。本提案描述了一种新型DNA的应用 裂解酶片段长度多态(CFLP)指纹技术 以确定丙型肝炎病毒基因分型。第二阶段的具体目标是 制作双管齐下的CFLP丙型肝炎病毒基因分型试剂盒，用于快速鉴定 广泛的丙型肝炎病毒类型和亚型。这个套装会很合适 为了分析高度保守的5‘NCR亚基因组区域 广泛使用的丙型肝炎病毒检测系统以及分析的后续进展 用于高分辨率基因分型的NS-5b区。签名元素 将使用CFLP裂解模式来鉴定基因 未确定特征的样本。第二阶段的提案包括内部 验证测试和Beta站点测试在两个重要参考文献中 实验室。CFLP丙型肝炎病毒基因分型试剂盒将能够区分丙型肝炎病毒 基因分型的可信度高达98%(对于单碱基变化，&gt；98% 构成基因分型基础的多个多态)时间更短 而且成本比现有方法更低。 建议的商业应用 丙型肝炎病毒(丙型肝炎病毒)的基因分型正在迅速发展 研究和临床实践领域。除了影响 对干扰素的反应性，丙型肝炎病毒可能是一个重要的 在未来的抗病毒治疗评估中的因素。CFLP是一种快速、 准确、用户友好的丙型肝炎病毒基因分型方法。通过开发一种 双管齐下，我们建议创造一种适合即时检测的产品 检测常见基因型别的临床应用(基于 5‘NCR亚基因组区域)，以及一种更深远的方法 更高分辨率的打字(基于NS-5b区域)。

Hepatitis C virus (HCV) is a widespread, persistent disease affecting 1- 2% of the world's population. Only a fraction of HCV affected individuals respond to interferon therapy. Viral genotype has emerged as a clinically significant predictor for determining response to interferon. This proposal describes the application of a novel DNA fingerprinting technology, Cleavase Fragment Length Polymorphism (CFLP) to identifying HCV genotype. The specific aims of Phase II are to generate a two-pronged CFLP HCV genotyping kit for rapid identification of a broad range of HCV types and subtypes. This kit will be suitable for analysis of the highly conserved 5'NCR subgenomic region as a follow-on to widely used HCV detection systems as well as for analysis of the NS-5b region for high-resolution genotyping. Signature elements of CFLP cleavage patterns will be used to identify genotype in uncharacterized samples. The Phase II proposal includes internal validation testing and beta site testing in two prominent reference labs. The CFLP HCV genotyping kit will be capable of discriminating HCV genotype with up to 98% certainty (for single base changes, >98% for the multiple polymorphisms that form the basis of genotyping) in less time and for a lower cost than existing methods. PROPOSED COMMERCIAL APPLICATION Genotypic identification of hepatitis C Virus (HCV) is a rapidly growing area of research and clinical practice. In addition to affecting responsiveness to interferon, HCV genotype is likely to be an important factor in the evaluation of future antiviral therapies. CFLP is a fast, accurate, and user-friendly method for HCV genotyping. By developing a two-pronged assay, we propose to create a product suitable for immediate clinical use in detecting commonly occurring genotypes (based on the 5'NCR subgenomic region) as well as a more far-reaching method for higher-resolution typing (based on the NS-5b region).