Universal Rapid test for HIV Diagnosis

HIV 诊断的通用快速检测

• 批准号: 10761415
• 负责人: Maria-Jose Miguez
• 金额: $ 29.49万
• 依托单位: IGE IMMUNO DIAGNOSTIC SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-11 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10761415
• 关键词: Acquired Immunodeficiency Syndrome; Acute; Address; Adolescent and Young Adult; Adult; Age; Antibodies; Antigens; Appearance; Applications Grants; Area; Avidity; Binding; Biological; Biological Assay; Biotechnology; Blood; Businesses; COVID-19 pandemic; Caring; Child; Childhood; Collaborations; Collection; Complex; Country; Data; Detection; Development; Devices; Diagnosis; Disease Outcome; Dose; Early Diagnosis; Early identification; Ecosystem; Ensure; Enzyme-Linked Immunosorbent Assay; Epidemic; Equipment; FDA approved; Feedback; Fingers; Florida; Future; Generations; Goals; HIV; HIV Infections; HIV diagnosis; Health system; Home; Human immunodeficiency virus test; IgE; Immunoassay; Immunodiagnostics; Immunoglobulin G; Immunoglobulin M; Individual; Industrial Health; Infant; Infection; Infrastructure; Innovation Corps; Instruction; International; Interview; Marketing; Mentors; Methods; Minority; Modeling; Monoclonal Antibodies; Mothers; Newborn Infant; Newly Diagnosed; Outcome; Participant; Peptides; Persons; Phase; Plasma; Polymerase Chain Reaction; Population; Populations at Risk; Positioning Attribute; Preclinical Testing; Prevention; Price; Privacy; Public Health; RNA; Reaction Time; Recommendation; Research; Resources; Risk; Saliva; Sampling; Sensitivity and Specificity; Serology; Services; Source; System; Test Result; Testing; United States; United States National Institutes of Health; Update; Vertical Disease Transmission; Viral; Viral Load result; Work; acute infection; antibody test; antigen test; barrier to testing; biobank; care providers; cohort; commercialization; cost effective; design; detection limit; experience; high risk; improved; innovation; interest; marginalized population; meetings; multidisciplinary; patient engagement; point of care; point of care testing; pre-exposure prophylaxis; preference; programs; prospective; prototype; rapid test; recruit; research and development; response; sample collection; self testing; seroconversion; success; testing uptake; transmission process; usability

The Problem: Approximately 38 million people worldwide are infected with HIV, with nearly 40% of them being unaware of their HIV status.4-8 A similar phenomenon has been observed in the United States, particularly in the southern parts of the country. Cases are becoming more common among adolescents and young adults (AYAs), and although routine HIV testing is now recommended and more widely available, yet HIV testing is sparce among them. Therefore, timely identification is needed to enhance disease outcomes and minimize HIV transmission, and our accurate self-testing format offers a viable solution to expand diagnosis. As a point of care test, the ability of the test to provide accurate antigen and antibody test results in less than 30 minutes will allow care providers to detect HIV infection and engage the patient(s) in care immediately. Individuals participating in either the pre-exposure prophylaxis (PrEP) or in the mother to child prevention transmission programs (MTC) will also benefit from such a test. Approach: To address this problem, IgE ImmunoDiagnostics, Inc. proposes adapting their successful IgE-HIV ELISA (98/95% sensitivity and specificity) to a rapid test format. The team will develop a 5th generation Ag/Ab combo system with the help of a select group of Bioamerica Inc research and development leaders. The team expects to surpass their prior test, maximizing overall sensitivity and specificity, thus outperforming existing commercially available rapid tests, and have near equivalence to the more complicated PCR tests. The specific AIMs for achieving this goal are as follows: AIM1: To conduct 100 customer discovery interviews in South Florida a major HIV epicenter. Participants will be recruited in an intended use setting, specifically on the PrEP and the MTC ecosystems. The goal is to identify unmet needs, preferences, facilitators, and barriers to test uptake. This aim employs the I-Corps framework and builds on the PI’s three decades of HIV research, Baños national and international work on commercialization and the experience of the FIU Start-up mentor with the entire model. AIM 2: To identify and optimize critical components of the serological part of the combo test. Based on IgE Immunodiagnostic experience gained while developing prior tests and the R&D expertise of BioAmerica, Inc, we will identify the optimal combination of antibodies and antigens to support the identification of HIV during acute infection (HAI). AIM 3: To identify the best sample(s) to support HIV testing in children and adults using the rapid test platform. AIM 4: Collaboration with our biotechnology partners to produce specific IgE monoclonal antibodies based on the selected peptides in milestone Aim2-a for the development of the antigen piece of the Combo test. Innovation: Building on our prior success, our test will be unique in that it will be: • an IgE based rapid test • 5th generation test, • incorporating multiple antigens and • useful in both children and adults. In addition, we will provide new data by contrasting active IgE and passively acquired IgM binding and time responses from mother-infant pairs. Feasibility: The team expertise in key R&D areas, and the resources made available through our academic, industrial, and public health partnerships ensures the success of this proposal. Outcomes: Our updated universal rapid test will advance diagnosis by permitting the early identification of HIV in both children and adults. Our simple, rapid and equipment free test, which allows testing in the privacy of one’s own home, will expand HIV testing. Finally, the study will be a great source of data to the field and to support new grant applications.

问题：全世界大约有 3800 万人感染艾滋病毒，其中近 40% 的人不知道这一点 他们的艾滋病毒状况。4-8 在美国也观察到类似的现象，特别是在美国南部地区。 尽管进行了常规艾滋病毒检测，但病例在青少年和年轻人 (AYA) 中变得越来越常见。 现在已被推荐并得到更广泛的应用，但艾滋病毒检测却很少，因此，及时识别是很困难的。 需要增强疾病结果并最大限度地减少艾滋病毒传播，我们准确的自我测试格式提供了可行的方法 作为扩大诊断范围的解决方案，该测试能够提供准确的抗原和抗体测试结果。 在不到 30 分钟的时间内，护理人员就能检测到 HIV 感染并立即让患者接受护理。 参与暴露前预防 (PrEP) 或母婴预防传播的个人 程序（MTC）也将从这样的测试中受益：为了解决这个问题，IgE 免疫诊断公司提出。 该团队将把他们成功的 IgE-HIV ELISA（98/95% 灵敏度和特异性）调整为快速测试形式。 在 Bioamerica Inc 精选团队研发领导者的帮助下，第五代 Ag/Ab 组合系统。 该团队希望超越他们之前的测试，最大限度地提高整体灵敏度和特异性，从而超越现有的测试 商业上可用的快速测试，并且与更复杂的 PCR 测试几乎相同。 实现这一目标的具体步骤如下： AIM1：在主要艾滋病毒震中南佛罗里达州进行 100 次客户发现访谈。 参与者将在预期用途环境中招募，特别是在 PrEP 和 MTC 生态系统中。 确定未满足的需求、偏好、促进因素和测试采用的障碍。该目标采用 I-Corps 框架和 建立在 PI 三十年的艾滋病毒研究、Baños 国内和国际商业化工作以及 金融情报机构初创导师在整个模型方面的经验 目标 2：识别和优化关键组件。 组合测试的血清学部分基于开发先前测试时获得的 IgE 免疫诊断经验。 凭借 BioAmerica, Inc 的研发专业知识，我们将确定抗体和抗原的最佳组合来支持 急性感染期间艾滋病毒的鉴定 (HAI) 目标 3：确定支持儿童和儿童艾滋病毒检测的最佳样本。 使用快速检测平台的成人 AIM 4：与我们的生物技术合作伙伴合作生产特定的 IgE 单克隆抗体。 基于里程碑 Aim2-a 中所选肽的抗体，用于开发组合测试的抗原片段。 创新：在我们之前的成功基础上，我们的测试将是独一无二的，因为它将： • 基于 IgE 的快速测试 • 第五代 测试， • 结合多种抗原， • 对儿童和成人都有用。 此外，我们将提供新数据。 对比母婴对的主动 IgE 和被动获得的 IgM 结合和时间反应 可行性：该团队。 关键研发领域的专业知识以及通过我们的学术、工业和公共卫生提供的资源 合作伙伴关系确保了该提案的成功：我们更新的通用快速测试将通过以下方式推进诊断。 我们的检测简单、快速且无需设备，可以及早识别儿童和成人的艾滋病毒。 最后，这项研究将成为该领域的重要数据来源。 并支持新的拨款申请。