MULTIPLEX RT-PCR BASED TEST FOR HIV-1, HTLVI/II, HCV

基于多重 RT-PCR 的 HIV-1、HTLVI/II、HCV 检测

• 批准号: 2735260
• 负责人: MARK M MANAK
• 金额: $ 37.07万
• 依托单位: SERACARE BIOSERVICES
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-06-01 至 1999-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2735260
• 关键词: deltaretrovirus; diagnosis design /evaluation; diagnostic tests; hepatitis B virus group; human T cell lymphotropic virus type 1; human T cell lymphotropic virus type 2; human immunodeficiency virus 1; human subject; nucleic acid hybridization; polymerase chain reaction; serology /serodiagnosis; uridine triphosphate

Despite the use of highly sensitive serologic tests for screening blood donations for antibodies to HIV-1, HTLV-I/II, HCV and HBV in US blood centers, the delay between the onset of infection and the antibody response creates a "window" period during which the blood may be infectious but seronegative. As a result, a low risk of virus transmission due to contaminated blood products still exists. During PHASEI of this grant, we have developed a Multiplex RT-PCR based capture assay which permits the simultaneous direct detection of HTLV-I/II, HIV-1, HCV and HBV in a single assay. In the course of PHASE II, we propose to further refine this Multiplex RT-PCR assay, and to develop a kit format useful for routine screening of blood products in a clinical lab setting. The assay will be validated on a number of well characterized performance and seroconversion panels for all five viruses and on large numbers (>1,000) of blood samples from normal blood donors. This test will provide a highly sensitive, cost-effective direct measure of infectious virus in blood and help further reduce the antibody-negative "window" period between infectivity and detection.

尽管使用高灵敏度的血清学检测筛查血液 捐赠美国血液中的HIV-1、HTLV-I/II、HCV和HBV抗体 中心，感染和抗体之间的延迟 反应产生了一个“窗口”期，在此期间，血液可能会 传染性但血清反应阴性 因此，感染病毒的风险较低 由于受污染的血液制品造成的传播仍然存在。 期间 在该基金的第一阶段，我们开发了一种基于多重RT-PCR的捕获 允许同时直接检测HTLV-I/II，HIV-1， HCV和HBV在一个单一的检测。 在第二阶段，我们建议 进一步完善这种多重RT-PCR检测，并开发试剂盒形式 可用于临床实验室环境中血液制品的常规筛选。 将根据许多充分表征的性能对该测定进行验证 所有五种病毒的血清转化板， （> 1，000）份来自正常献血者的血液样本。 本测试将 提供了一种高度敏感、具有成本效益的直接测量传染性的方法， 血液中的病毒，并帮助进一步减少抗体阴性的“窗口” 感染和检测之间的时间。