LOW COST HIV DRUG RESISTANCE MONITORING

描述：（改编自申请人的摘要）Jack U 'Ren博士，Paul Haydock和Sharon霍华德（Saigene公司[正式诊断 MicroProbe Corporation的部门]，博瑟尔，WA）建议开发 一种低成本的HIV耐药监测方法。该产品将同时 快速定量病毒载量并识别HIV逆转录病毒中的突变 转录酶基因目前，还没有产品可以同时测量 病毒载量，并确定耐药突变，同时从 同样的样品。总体目标将通过执行 定量PCR，然后检查已知突变体处的探针结合 在HIV RT基因中的位置。在第一阶段，该检测方法将开发为 通过专注于PCR条件、引物、捕获序列和 定量检测野生型和药物的内标物- 抵抗艾滋病毒。然后使用以下方法评价开发的检测试剂盒： 耐药HIV病毒株的特征。在第二阶段，试验将 扩大到其他药物和药物组合，并将采用临床 样品这些结果将与更昂贵的DNA测序进行比较 正在进行的临床研究的方法。最终的临床应用 将为患者管理提供耐药性信息， 因此，了解耐药突变的确切性质， 预测交叉耐药性或对其他药物的耐药性降低。

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.