Point-of-Care HIV Antigen/Antibody Diagnostic Device

HIV 抗原/抗体即时诊断设备

基本信息

批准号：
8140839
负责人：
MICHAEL J LOCHHEAD
金额：
$ 19.75万
依托单位：
MBIO DIAGNOSTICS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-08-10 至 2012-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8140839
关键词：
Accident and Emergency department Acute Algorithms Antibodies Antigens Antiviral Agents Appearance Archives Award Awareness Bedside Testings Biological Assay Biological Sciences California Caring Chairperson Clinic Clinical Collection Communicable Diseases Complement Detection Development Devices Diagnosis Diagnostic Disease Doctor of Philosophy Engineering Enzymes FDA approved Generations Goals Gold Growth HIV HIV Antibodies HIV Antigens HIV Core Protein p24 HIV Infections HIV-1 Head Human immunodeficiency virus test Immunoassay Individual Industry Infection Laboratories Magnetism Marketing Medicine Methods Modeling Mozambique Nucleic Acid Amplification Tests Performance Persons Phase Plasma Program Research Project Grants Public Health Research Research Personnel Sampling Scientist Screening procedure Serological Serum Site Small Business Innovation Research Grant Source System Technology Testing Text Time Translational Research United States United States National Institutes of Health Universities Validation Veterans Viral Antigens base clinically relevant commercialization cost cost efficient improved instrument novel outreach program particle photonics point of care programs prototype transmission process

项目摘要

DESCRIPTION (provided by applicant): MBio Diagnostics, Inc. proposes to develop a low-cost, point-of-care (POC), HIV-1 antigen/antibody combination diagnostic device. The goal is for the Ag/Ab combo system to deliver the performance of laboratory based, 4th generation antigen/antibody clinical analyzers, in a POC platform with cost and workflow of the widely used HIV rapid tests. This Phase I proposal will focus on development of a novel, multiple particle approach for a HIV-1 p24 antigen sandwich immunoassay that will deliver clinically relevant limits of detection. During Phase II, the p24 assay will combined with MBio's multiplexed HIV-1/2 antibody detection system. If successful, the resulting minimally instrumented Ag/Ab combination assay would be the most sensitive POC HIV screening technology available. HIV infection remains a major public health crisis both in the United States and worldwide. There is increasing awareness that acutely infected individuals disproportionately contribute to disease spread. Yet these individuals remain the most difficult to identify, as infectivity is highest prior to the appearance of the HIV antibodies that serve as the basis for serological diagnostics. There are currently no FDA-approved point-of-care (POC) tests that directly target HIV viral antigens. An HIV-1 antigen/antibody (Ag/Ab) combination assay - the so-called "4th generation" immunoassay - in an inexpensive, simple to use, POC format would fundamentally improve HIV-1 screening efforts in the United States and worldwide. The specific aims of this proposal are to: (1) Establish a core collection of well characterized clinical serum/plasma samples focused on acute and recent HIV infection. The Phase I collection will be based on samples from existing archives and sources, with additional testing under this award. The Phase I milestone will be a collection of 60 HIV-1 positive and 40 negative sera. (2) Demonstrate MBio's magnetic multi-particle approach for rapid, ultra-sensitive, no- enzyme detection of HIV p24 antigen. The milestone for this aim is a model assay standard curve for p24 antigen detection with a lower limit of detection of 20 pg/mL. (3) Quantitatively compare performance of the MBio antigen/antibody assay on the Aim 1 recent infection panel with gold-standard methods. The milestone for this aim is detection of 80% of HIV-1 positive samples not detected with the current market- leading FDA-approved HIV-1/2 rapid test. Upon successful completion of the Phase I project, device engineering and a larger clinical validation leading to an FDA investigational device exemption (IDE) will be proposed under Phase II. PUBLIC HEALTH RELEVANCE: The proposed point-of-care (POC) HIV-1 Ag/Ab combination diagnostic device will fill a critical unmet need for HIV screening technologies that detect recent and acutely infected individuals. The technology will be used in multi-test algorithms in public health laboratories, STD clinics, urban emergency departments, targeted outreach programs,etc., both in the United States and worldwide.

描述（由申请人提供）：MBIO Diagnostics，Inc。提议开发低成本，护理点（POC），HIV-1抗原/抗体组合诊断设备。目的是让AG/AB组合系统在POC平台中提供基于实验室的第四代抗原/抗体临床分析仪的性能，其成本和工作流程广泛使用的HIV快速测试。该阶段I提案将集中于开发用于HIV-1 P24抗原三明治免疫测定的新型，多种粒子方法，该方法将提供临床上相关的检测限制。在II期期间，P24分析将与MBIO的多重HIV-1/2抗体检测系统结合使用。如果成功，最低仪器的AG/AB组合测定法将是最敏感的POC HIV筛查技术。艾滋病毒感染仍然是美国和全球的重大公共卫生危机。越来越多的意识到，急性感染的个体不成比例地促进疾病的传播。然而，这些人仍然是最难识别的，因为在出现HIV抗体之前，感染力是血清学诊断基础的最高。目前没有直接靶向HIV病毒抗原的FDA批准的电位（POC）测试。 HIV-1抗原/抗体（AG/AB）组合测定法 - 所谓的“第四代”免疫测定 - 在廉价，易于使用的易POC格式中，POC格式从根本上可以改善美国和全球范围内的HIV-1筛查工作。该提案的具体目的是：（1）建立一个针对急性和最近HIV感染的临床血清/血浆样品的核心收集。第一阶段的收集将基于现有档案和资源的样本，并根据此奖项进行其他测试。第一阶段的里程碑将是60 HIV-1阳性和40个负血清的集合。（2）展示了MBIO的磁性多粒子方法，用于快速，超敏感，无酶检测HIV P24抗原。该目标的里程碑是用于P24抗原检测的模型测定标准曲线，检测下限为20 pg/ml。（3）定量比较AIM 1最近感染面板上MBIO抗原/抗体测定的性能。该目标的里程碑是检测到当前领先的FDA批准的HIV-1/2快速测试未检测到的80％的HIV-1阳性样品。成功完成I期项目后，设备工程和更大的临床验证将在II期下提出，从而导致FDA研究设备豁免（IDE）。公共卫生相关性：拟议的护理点（POC）HIV-1 AG/AB组合诊断装置将满足对检测最近和急性感染个体的HIV筛查技术的关键需求。该技术将用于公共卫生实验室，性病诊所，城市急诊科，有针对性的外展计划等的多项测试算法。