Smartphone-based POC Testing for HIV Using Glowstick Chemistry

基于智能手机的 HIV 使用荧光棒化学进行 POC 测试

基本信息

批准号：
10594143
负责人：
Richard Willson
金额：
$ 45.65万
依托单位：
UNIVERSITY OF HOUSTON
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-01-06 至 2025-12-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10594143
关键词：
Acids Address Adolescent Affinity African American Android Antibodies Antigen-Antibody Complex Archives Avidity Binding Blood Bulla Cellular Phone Chemicals Chemistry Clinic Clinical Collaborations Communicable Diseases Detection Development Diagnostic Diagnostic Procedure Dissociation Early Diagnosis Early treatment Ensure Enzyme-Linked Immunosorbent Assay Epitopes Fibronectins Fluorescence Polarization Formulation Goals HIV HIV Infections HIV Seropositivity HIV diagnosis Health Health system Hispanic Home Human Human immunodeficiency virus test Immunoassay Infection Instruction Interruption Kinetics Lateral Libraries Ligands Light Link Liquid substance Materials Testing Measurement Medical Modeling Monitor Optics Patients Performance Persons Phage Display Phase Population Population Heterogeneity Populations at Risk Readability Reading Reagent Reporter Research Resources Risk Sampling Source Specimen Technology Testing Time Translating Viral Load result Visit Work acute infection analog antigen detection antiretroviral therapy biobank cohort cost demographics detection limit falls fluorophore high risk improved innovation insight lateral flow assay manufacture member novel particle pediatric human immunodeficiency virus point of care pre-exposure prophylaxis prevent protein biomarkers quality assurance recruit scaffold seal self testing seroconversion test strip transmission process usability

项目摘要

Effective testing for HIV allows for detection of acute infections (new and rebound), appropriate antiretroviral treatment, suppression of viral load, and interruption of transmission. However, early detection of infection or regular self-monitoring at point-of-need or at home remains a challenge. Lateral flow assays are a well-established, inexpensive point-of-need diagnostic method, and commonly are favored when applicable because of their ease of use and low cost. Where they most commonly fall short is in analytical sensitivity, notably in antigen-detection diagnostics for infectious diseases. Our goal is to develop radically-improved LFAs by implementing the inexpensive, shelf-stable chemi-excitation chemistry of glow sticks in a point-of-care format to excite fluors without light or optical filters. Our preliminary results suggest this chemistry enables LFAs with greatly improved limits of detection (very low pg/mL), using a standard smartphone with a $2 adaptor and no sophisticated optical components. Our central hypothesis is that our novel, reagent-optimized chemi-excited lateral flow assay technology integrated with a storage-stable reagent cartridge and readable with a smartphone will lead to a new, widely-useful and potentially very-superior class of highly-sensitive lateral flow assays. We will test this hypothesis through 5 specific aims: (1) Development of a highly-sensitive and easily-usable lateral flow assay for HIV p24 in human blood, including development of novel avidity-enhanced dual-fibronectin-domain binders, (2) Immune complex dissociation (ICD) for rebound/breakthrough HIV diagnosis, (3) Testing with 300 negative and archived-positive human samples from diverse cohorts, (4) To evaluate clinical performance using fresh samples from patients and usability with a diverse population of subjects at high risk of HIV infection/rebound (R33 Phase), (5) Easier usability by more people, quality assurance for test items (R33 Phase).

艾滋病毒的有效测试可以检测急性感染（新反弹和反弹），适当抗逆转录病毒治疗，病毒负荷的抑制和传播中断。但是，早在需要的地方或在家中发现感染或定期自我监控仍然是一个挑战。侧流量测定是一种良好，廉价的诊断方法，通常是由于使用易用性和低成本而受到适用时的青睐。他们最常见的地方简短具有分析灵敏度，特别是在传染病的抗原检测诊断中。我们的目标是通过实施廉价且稳定的稳定性来开发从根本改良的LFA 发光棒的化学兴奋化学以一种护理格式的格式激发荧光，没有光或光学过滤器。我们的初步结果表明，这种化学能够使LFA大大改善的限制检测（非常低的PG/mL），使用带有2美元适配器的标准智能手机，没有复杂的光学成分。我们的中心假设是我们的新颖，试剂极优化的化学激发横向流动分析技术与储存稳定的试剂墨盒集成并使用智能手机可读将导致新的，广泛的，潜在的非常敏感的侧向流动测定。我们将通过5个具体目的来检验这一假设：（1）开发高度敏感的和易于使用的HIV P24在人类血液中的横向流量测定，包括新型的发展亲自增强双基因蛋白域的粘合剂，（2）免疫复合物解离（ICD）反弹/突破性的艾滋病毒诊断，（3）300个阴性和存档阳性人的测试来自不同队列的样本，（4）使用患者的新鲜样品评估临床表现以及具有艾滋病毒感染/反弹高风险的受试者的可用性（R33期），（5）更多的人更容易使用，测试项目的质量保证（R33阶段）。