Point-of-Care Rapid RNA test for HIV

用于HIV的床旁快速RNA检测-第2阶段 CrossLife Technologies Inc. 项目概要/摘要 目前的抗体即时检测无法区分母亲和婴儿的 检测婴儿是否感染人类免疫缺陷病毒的抗体 病毒（HIV）。根据世卫组织/艾滋病规划署/儿童基金会最近的一份报告， 艾滋病毒阳性母亲所生的婴儿中， 月[1]。因此，对于新的和翻新的测试存在未满足的需求， 应用于检测艾滋病毒感染的护理点。一种快速、灵敏、特异、简单的 在护理点检测艾滋病毒的具有成本效益的试纸分子测试是 通过整合塔拉化学和设备创新而开发。靶序列 使用塔拉（模板辅助快速测定）技术扩增， 由具有高周转率的模板依赖性化学转移反应组成，金 纳米颗粒-HRP和侧向流读数。测试应快速（<30分钟），并且 导致出现肉眼可检测到的有色条带。所得 类似于怀孕测试的盒将自动化分子分析的所有步骤， 扩增用于检测血液手指针刺中的HIV RNA，无需样品制备。 在第1阶段，我们证明了100%的灵敏度和特异性，我们的测定对一个小的 模拟临床样本数量。这远远高于对非洲国家的研究报告的水平。 Alere Q和桑巴舞床旁HIV检测试剂盒[52-53]。 该第二阶段提案的目标是1）用于塔拉测定的纸质微流体 自动化，2）验证我们的塔拉艾滋病毒测试的性能，使用大量的 临床样本（n=400），然后3）寻求世界卫生组织（WHO） 加快审查批准和建议采购我们的产品。后 在第二阶段开发的测试的初步营销中，我们计划在 允许未经培训的非专业人员操作测试。这种做法在很大程度上是由于 为进一步制定《公约》所需的延长预算和时间轴， 我们的测试让它免于CLIA的制裁我们的测试将比RT-PCR测试更快速 因为结果将在需要时提供，而不是在实验室， 仪器已就位。

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.