Point-of-Care Rapid RNA test for HIV

HIV-2期的照顾点快速RNA检测 CrossLife Technologies Inc. 项目摘要/摘要 目前的抗体护理点检测无法区分母亲和婴儿的 用于检测婴儿是否感染了人类免疫缺陷的抗体 病毒(HIV)。根据世卫组织/联合国艾滋病规划署/联合国儿童基金会最近的一份报告，预计只有28 艾滋病毒阳性母亲所生的婴儿在前两个月内接受了艾滋病毒检测 月[1]。因此，对新的和翻新的测试有未满足的需求，可以 在护理地点应用，以检测艾滋病毒感染。一种快速、灵敏、具体的简单 在护理地点检测艾滋病毒的经济实惠的纸条分子测试是 通过整合Tara化学和设备创新而开发。靶序列 使用TARA(模板辅助快速检测)技术进行扩增 由模板相关的化学转移反应组成，具有高转化率，金 纳米粒子-HRP和侧向流动读数。测试应快速(&lt；30分钟)，以及 导致肉眼可检测到的彩色条带的出现。由此产生的 类似于怀孕测试的试剂盒将自动执行分子分析的所有步骤 无需样品制备的血液指棒中HIV RNA的扩增检测。 在第一阶段，我们证明了我们的检测在一个小的 模拟临床样本的数量。这远远高于研究报告的水平 Alere Q和Samba关怀点艾滋病毒检测[52-53]。 此第二阶段提案的目标是：1)纸质微流控检测塔拉 自动化，2)验证我们Tara HIV检测的性能，使用大量 临床样本(n=400)，然后3)遵循世界卫生组织(WHO) 加快对我们产品采购的审查、批准和建议。之后 在第二阶段开发的测试的初步营销，我们计划在#年寻求CLIA豁免 为了允许未经培训的非专业人员操作测试。这种方法在很大程度上是由于 将需要延长的预算和时间表，以涵盖进一步的发展 我们放弃了让它成为CLIA的测试。我们的检测将比RT-PCR检测更快 因为结果将在需要的时候得到，而不是在实验室里 仪器已定位。

Point-of-Care Rapid RNA test for HIV—Phase 2 CrossLife Technologies Inc. Project Summary/Abstract Current antibody point-of-care tests cannot distinguish between a mother's and baby's antibodies to detect if an infant has become infected with Human Immunodeficiency Virus (HIV). According to a recent WHO/UNAIDS/UNICEF report, only a predicted 28 percent of babies born to HIV-positive mothers obtained an HIV test within the first two months [1]. Therefore, there are unmet needs for new and renovated test that can be applied at the point-of-care to detect HIV infections. A rapid, sensitive, specific simple and cost-effective paper strip molecular test that detects HIV at the point-of-care was developed by integrating TARA chemical and device innovations. The target sequences are amplified using the TARA (Template Assisted Rapid Assay) technology which is composed of a template-dependent chemical transfer reaction with high turnover, gold nanoparticle-HRP, and lateral flow readout. The test should be rapid (<30 minutes), and results in the appearance of colored bands that are detectable by eye. The resulting cartridge similar to a pregnancy test will automate all steps of molecular analysis and amplification for detection of HIV RNAs in blood finger-stick without sample preparation. In Phase 1, we demonstrated 100% sensitivity and specificity for our assay on a small number of simulated clinical samples. This is well above levels reported in studies of the Alere Q and SAMBA point of care HIV assays [52-53]. The goal of this Phase 2 proposal is to 1) Paper microfluidics for TARA assay automation, 2) verify the performance of our TARA HIV test using a large number of clinical samples (n=400), and then 3) pursue World Health Organization (WHO) expedited review approval and recommendation for procurement on our product. After initial marketing of the test developed in Phase 2, we plan to pursue CLIA waiver in order to allow for untrained, lay persons to operate the test. This approach is largely due to the extended budget and timeline that will be required to cover further development of our test to make it CLIA-waived. Our test will be more rapid than the RT-PCR tests because the results will be available at the point-of-need and not in a laboratory where the instrument is located.