A Rapid Multiplexed Assay for the Diagnosis of Viral Hepatitis at the Point of Care

即时诊断病毒性肝炎的快速多重检测

• 批准号: 10005702
• 负责人: Johann Desa
• 金额: $ 57.29万
• 依托单位: INSTADIAGNOSTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2023-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10005702
• 关键词: Rapid; Multiplexed; Assay; Diagnosis; Viral

Instadiagnostics (IDI) is developing a point-of-care (POC) diagnostic technology platform with the goal of providing early detection, screening, and treatment monitoring for patients at primary care centers, community clinics, urgent care centers, and emergency departments. The device consists of a portable reader (the InstaReader) and disposable cartridges (InstaCartridge). A range of disease specific cartridges will allow for multiple diseases be detected on a single device. The system’s ability to provide clinical laboratory quality results in less than 15 minutes will give medical workers the capability to immediately diagnose patients, and allows patients to avoid additional trips to have blood drawn, lengthy wait times for results, or delays in diagnosis and follow up testing. IDI’s diagnostic platform will improve patient care/satisfaction, medical outcomes, and workflow for healthcare providers, while reducing overall medical costs. In response to the call for proposals issued by the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, the goal of the proposed work is to develop a rapid multiplexed blood test for point of care evaluation of patients at risk for viral hepatitis, specifically this proposal is focused on the POC screening for hepatitis C virus (HCV). It is estimated that 3.5 million Americans have chronic HCV infections and the rate of new HCV infections has increased further in recent years. Chronic hepatitis infections are treatable for nearly all patients and treatments result in significant reductions in liver-related morbidity and mortality. Treatments are most effective and cost-effective when initiated early in the disease course, before the onset of liver cirrhosis. However, up to 50% of those with HCV are unaware of their infections and therefore not referred for treatment evaluation. A known barrier to screening is the accessibility to testing labs and/or POC tests. Therefore, an improved, readily available method of screening high-risk individuals for chronic viral hepatitis at the POC is essential to improve prognosis for infected individuals. The specific aims of the proposed Phase II SBIR project are to: 1. Optimize the rapid HCV antibody screening assay: This involves optimizing the assay cutoff to cover low to high HCV antibody levels, demonstrating detection across genotypes, and storage and stability studies 2. Develop clinic-ready InstaReaders and HCV specific disposable InstaCartridges: This aim results in the development of multiple InstaReaders and InstaCartridges that will be thoroughly tested for POC operation. 3. Conduct a pilot HCV clinical study at the POC: Here the entire system will be tested for the screening of patients at the UTSWMC clinic. This aim will demonstrate equivalent performance to FDA approved laboratory tests.

Instadiagnostics（IDI）正在开发一种床旁（POC）诊断技术平台，其目标是 为初级保健中心、社区和社区的患者提供早期发现、筛查和治疗监测 诊所，紧急护理中心和急诊室。该设备包括一个便携式阅读器（ InstaReader）和一次性检测盒（InstaCartridge）。一系列疾病特异性药筒将允许 在一台设备上检测多种疾病。系统提供临床实验室质量的能力 在不到15分钟的时间内得出结果，将使医务工作者能够立即诊断病人， 允许患者避免额外的旅行抽血，等待结果的漫长时间，或延迟， 诊断和后续测试。IDI的诊断平台将改善患者护理/满意度，医疗 结果和工作流程，同时降低整体医疗成本。 为响应国家艾滋病毒/艾滋病、病毒性肝炎、性病和结核病中心发出的提案呼吁， 预防，拟议工作的目标是开发一种快速多重血液检测的护理点 评估有病毒性肝炎风险的患者，特别是本提案侧重于POC筛查， 丙型肝炎病毒（HCV）。据估计，350万美国人患有慢性HCV感染， 近年来，新的HCV感染进一步增加。慢性肝炎感染可治疗近 所有患者和治疗均导致肝脏相关发病率和死亡率的显著降低。治疗 最有效和最具成本效益时，开始在疾病过程的早期，在肝脏发病之前， 肝硬化然而，高达50%的HCV感染者不知道自己的感染，因此没有被转诊。 治疗评价筛查的一个已知障碍是测试实验室和/或POC测试的可访问性。 因此，有一种改进的、现成的方法来筛查高危个体的慢性病毒性肝炎， POC对于改善受感染个体的预后至关重要。 拟议的第二阶段SBIR项目的具体目标是： 1.优化快速HCV抗体筛查检测：这涉及优化检测临界值， 从低到高的HCV抗体水平，证明了跨基因型的检测，以及储存和稳定性 研究 2.开发临床就绪的InstaReader和HCV专用一次性InstaCartridges：这一目标导致 开发多个InstaReader和InstaCartridges，将对POC进行全面测试 操作 3.在POC进行试点HCV临床研究：在这里，整个系统将进行测试，以筛选 UTSWMC诊所的患者。这一目标将证明与FDA批准的 实验室测试