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

Project Summary/Abstract: 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.