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：全世界约有3800万人感染艾滋病毒，其中近40%的人不知道 4 -8在美国也观察到类似的现象，特别是在美国南部， 国家病例在青少年和年轻人（AYAs）中越来越常见，尽管常规的艾滋病毒检测 现在被推荐并且更广泛地使用，但艾滋病毒检测在他们中间很少。因此，及时识别是 需要加强疾病的结果和最大限度地减少艾滋病毒的传播，我们准确的自我检测格式提供了一个可行的 扩大诊断的解决方案。作为床旁检测，该检测提供准确抗原和抗体检测结果的能力 在不到30分钟的时间内，将使护理提供者能够检测到艾滋病毒感染，并立即对患者进行护理。 参与暴露前预防（PrEP）或预防母婴传播的个人 项目（MTC）也将受益于这样的测试。方法：为了解决这个问题，IgE ImmunoDiagnostics，Inc.提出 将其成功的IgE-HIV ELISA（98/95%灵敏度和特异性）调整为快速检测形式。该团队将开发一个 第五代Ag/Ab组合系统在Bioamerica Inc研发领导团队的帮助下推出。 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 这是商业上可获得的快速测试，并且与更复杂的PCR测试具有接近的等效性。具体目标为 实现这一目标的方法如下：目标1：在南佛罗里达一个主要的艾滋病中心进行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。目标是 确定未满足的需求、偏好、促进因素和测试吸收的障碍。这一目标采用了I-Corps框架， 建立在PI三十年的艾滋病毒研究，Baños国家和国际商业化工作以及 金融情报股创业导师对整个模式的经验。目的2：确定和优化的关键组成部分， combo测试的血清学部分。根据开发先前测试时获得的IgE免疫诊断经验和 BioAmerica，Inc的研发专业知识，我们将确定抗体和抗原的最佳组合，以支持 在急性感染（HAI）期间识别HIV。目标3：确定支持儿童艾滋病毒检测的最佳样本， 使用快速测试平台的成人。目标4：与我们的生物技术合作伙伴合作，生产特异性IgE单克隆抗体 基于里程碑Aim 2-a中所选肽的抗体，用于开发Combo检测的抗原片段。 创新：在我们先前成功的基础上，我们的测试将是独一无二的，因为它将是：·基于IgE的快速测试·第五代 测试，·纳入多种抗原和·适用于儿童和成人。此外，我们将通过以下方式提供新数据： 对比主动IgE和被动获得IgM结合和时间反应从母婴对。可行性：团队 在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 伙伴关系确保了这一提议的成功。结果：我们更新的通用快速检测将通过以下方式推进诊断： 从而能够在儿童和成人中及早发现艾滋病毒。我们简单，快速和设备免费测试，这使得 在自己家中进行检测，将扩大艾滋病毒检测。最后，该研究将成为该领域的重要数据来源 并支持新的赠款申请。