Point-of-Care Rapid RNA test for HIV

HIV 护理点快速 RNA 检测

• 批准号: 9770770
• 负责人: HyunDae Cho
• 金额: $ 99.58万
• 依托单位: CROSSLIFE TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9770770
• 关键词: Achievement; Acquired Immunodeficiency Syndrome; Antibodies; Appearance; Automation; Bedside Testings; Biological; Biological Assay; Blood; Blood specimen; Budgets; Buffers; Chemicals; Chemistry; Child; Clinical; Clinical Research; Clinical Sensitivity; Collaborations; Color; Complementary DNA; Data Set; Decision Making; Detection; Developing Countries; Development; Devices; Diagnosis; Diagnostic; Diagnostic tests; Emergency Situation; Engineering; Equipment; Evaluation; Eye; Failure; Feedback; Fingers; Goals; Gold; HIV; HIV Antibodies; HIV Infections; HIV Seronegativity; HIV Seropositivity; HIV diagnosis; HIV-1; Hepatitis B Virus; Hepatitis C virus; Human Resources; Human immunodeficiency virus test; Infant; Laboratories; Lateral; Liquid substance; Marketing; Methods; Microfluidics; Molecular; Molecular Analysis; Mothers; Nucleic Acid Amplification Tests; Nucleic Acids; Outcome Measure; Paper; Participant; Performance; Persons; Phase; Plasma; Power Sources; Pregnancy Tests; Preparation; RNA; RNA Viruses; RNA purification; Reaction; Reagent; Recommendation; Refrigeration; Reporting; Reproducibility; Research; Resources; Reverse Transcriptase Polymerase Chain Reaction; Sampling; Sensitivity and Specificity; Serum; Signal Transduction; Simplexvirus; Specificity; System; Technology; Testing; Time; TimeLine; Training; UNICEF; Validation; Whole Blood; Woman; World Health Organization; amplification detection; base; chemical transfer reaction; cost; cost effective; design; expedited review; innovation; instrument; instrumentation; meter; nanoGold; new technology; novel; point of care; prospective; prospective test; prototype; research clinical testing; usability; user-friendly; waiver

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.

HIV 护理点快速 RNA 检测 — 第 2 阶段 十字生命科技公司 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抗体 检测婴儿是否感染人类免疫缺陷的抗体 根据世界卫生组织/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 种病毒（艾滋病毒）。 艾滋病毒呈阳性的母亲所生的婴儿在头两年内接受艾滋病毒检测的百分比 因此，新的和翻新的测试的需求尚未得到满足。 应用于护理点检测 HIV 感染，快速、灵敏、特异性简单。 具有成本效益的纸条分子测试可在护理点检测艾滋病毒 通过整合 TARA 化学和设备创新而开发。 使用 TARA（模板辅助快速检测）技术进行扩增 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 和侧流读数 测试应该快速（<30 分钟），并且 导致出现肉眼可察觉的彩色条带。 类似于妊娠测试的试剂盒将自动执行分子分析的所有步骤 用于检测指尖采血中 HIV RNA 的扩增，无需样品制备。 在第一阶段，我们在小型试验中证明了我们的检测具有 100% 的灵敏度和特异性。 模拟临床样本的数量远高于研究报告的水平。 Alere Q 和 SAMBA 护理点 HIV 检测 [52-53]。 该第 2 阶段提案的目标是 1) 用于 TARA 测定的纸微流体 自动化，2) 使用大量数据验证我们的 TARA HIV 测试的性能 临床样本（n=400），然后3）追踪世界卫生组织（WHO） 加快审查批准和推荐我们的产品采购。 在第二阶段开发的测试的初步营销中，我们计划在 为了允许未经培训的非专业人士操作测试，这种方法很大程度上是由于。 延长预算和时间表，以涵盖进一步发展 我们的测试将使其获得 CLIA 豁免 我们的测试将比 RT-PCR 测试更快。 因为结果将在需要时提供，而不是在实验室中提供 仪器位于。