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

InstaDiagnostics(IDI)正在开发一个护理点(POC)诊断技术平台，目标是 在初级保健中心、社区为患者提供早期检测、筛查和治疗监控 诊所、紧急护理中心和急诊科。该设备由便携式阅读器( InstaReader)和一次性墨盒(InstaCartridge)。一系列疾病专用墨盒将允许 在一台设备上可以检测到多种疾病。该系统提供临床实验室质量的能力 不到15分钟的结果将使医务人员能够立即诊断患者，以及 允许患者避免额外的抽血行程、漫长的结果等待时间或延迟 诊断和跟踪测试。IDI的诊断平台将提高患者的护理/满意度，医疗 结果和医疗服务提供者的工作流程，同时降低总体医疗成本。 应国家艾滋病毒/艾滋病、病毒性肝炎、性传播疾病和结核病中心的号召 预防方面，拟议工作的目标是开发一种用于护理地点的快速多路血液检测 评估有病毒性肝炎风险的患者，具体地说，这项建议侧重于POC筛查 丙型肝炎病毒(HCV)。据估计，350万美国人患有慢性丙型肝炎病毒，而 近年来，新的丙型肝炎病毒感染进一步增加。慢性肝炎感染可治疗的时间接近 所有患者和治疗都显著降低了与肝脏相关的发病率和死亡率。治疗 最有效和最具成本效益的是在病程的早期，即在肝脏发病之前开始 肝硬变。然而，高达50%的丙型肝炎病毒携带者没有意识到他们的感染，因此没有转介给 治疗评价。筛查的一个已知障碍是测试实验室和/或PoC测试的可及性。 因此，一种改进的、现成的筛查慢性病毒性肝炎高危人群的方法 POC对于改善感染者的预后至关重要。 拟议的第二期SBIR项目的具体目标是： 1.优化丙型肝炎病毒抗体快速筛查试验：这涉及到优化试验截止范围以涵盖 从低到高的丙型肝炎病毒抗体水平，显示了跨基因型的检测以及储存和稳定性 研究 2.开发可供临床使用的InstaReader和丙型肝炎病毒特异性一次性InstaCartridles：这一目标导致 开发多个InstaReader和InstaCarbon，将针对POC进行全面测试 手术。 3.在POC进行试点丙型肝炎临床研究：在这里，整个系统将进行筛查 UTSWMC诊所的患者。这一目标将展示与FDA批准的同等性能 实验室检测。

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.