LOW COST HIV DRUG RESISTANCE MONITORING

描述：（改编自申请人的摘要）Drs。杰克·乌伦、保罗 Haydock 和 Sharon Howard（Saigene 公司 [正式诊断 MicroProbe Corporation 的部门]，Bothell，WA）提议开发 一种低成本的艾滋病毒耐药性监测方法。该产品将同时 快速量化病毒载量并识别 HIV 逆转中的突变 转录酶基因。目前尚无产品能够同时测量这两种情况 病毒载量并同时识别耐药突变 相同的样本。总体目标将通过执行来实现 定量 PCR，然后检查探针与已知突变体的结合 HIV RT 基因内的位置。在第一阶段，该检测将发展为 通过关注 PCR 条件、引物、捕获序列和 定量检测野生型和药物的内部标准 耐药艾滋病毒。然后将使用评估开发的测定法 具有耐药性的HIV病毒株的特征。在第二阶段，检测将是 扩展到其他药物和药物组合，并将应用于临床 样品。这些结果将与成本更高的 DNA 测序进行比较 正在进行的临床研究中的方法。最终的临床应用 将为患者管理提供耐药性信息， 这样，了解耐药突变的确切性质就可以 预测对其他药物的交叉耐药性或耐药性降低。

DESCRIPTION: (Adapted from applicant's abstract) Drs. Jack U'Ren, Paul Haydock and Sharon Howard (Saigene Corporation [formally the Diagnostic Division of the MicroProbe Corporation], Bothell, WA) propose to develop a low cost HIV drug-resistant monitoring assay. This product will both rapidly quantify viral load and identify mutations in the HIV reverse transcriptase gene. At present, no products exist which measure both viral load and identify drug-resistant mutations at the same time from the same sample. The overall aim will be accomplished by performing quantitative PCR followed by examining probe binding at known mutant locations within the HIV RT gene. In phase I, the assay will develop be developed by focusing on PCR conditions, primers, capture sequences, and internal standards which quantitatively detect wild type and drug- resistant HIV. The developed assay will then be evaluated using characterized drug-resistant HIV strains. In Phase II, the assay will be expanded to other drugs and drug combinations, and will employ clinical samples. These results will be compared to more costly DNA sequencing methods in ongoing clinical studies. The ultimate clinical application will be to provide drug resistance information for patient management, such that knowing the precise nature of a drug resistant mutation may predict cross-resistance or reduced resistance to other drugs.