Project Summary HCV is a major threat worldwide, infecting over 58 million people and causing 300,000 deaths from HCV-related cirrhosis or hepatocellular carcinoma (HCC) each year. Nigeria has approximately 2.2 million people living with HCV with prevalence rates ranging from 0.1-30% depending on the population and region. HCV contributes to about a quarter of HCC in Nigeria, which is the fifth leading cause of cancer and cancer related mortality in this country. Approximately 15-45% of persons infected with HCV will spontaneously clear the virus, therefore after testing positive on a serological test (anti-HCV), confirmation of HCV viremia with laboratory-based molecular HCV viral load (VL) testing is necessary to identify those who need treatment. In Nigeria and many other LMICs, access to laboratory-based VL tests remains limited and as a result many people screening positive for anti- HCV and with active HCV (defined as positive anti-HCV, detectable (>LLD) HCV RNA) are never linked to care and treatment. Successful treatment of HCV has significantly reduced the risk of HCV-related HCC. The lack of a single step point-of-care (POC) test for the diagnosis of active HCV infection both high- and low-and-middle income countries is a significant impediment to swift initiation of treatment impacting the ability to end the HCV epidemic and prevent long-term complications such as HCC. Here we propose to develop and validate an HCV test for the DASH™ platform for the diagnosis of active HCV at the point of care, by sensitively detecting HCV viral RNA, obviating the requirement for two-step serologic and laboratory based molecular testing. The DASH™HCV test is designed to be easily operated by non-laboratory personnel in settings that lack laboratory infrastructure. A capillary blood sample is simply collected by fingerstick, added to the test cartridge, and inserted into the DASH™ analyzer. After 15 minutes, an easy-to-read qualitative positive or negative result appears on the unit's touch screen. Following development, the diagnostic accuracy of DASH™ HCV will be evaluated on both stored plasma and prospectively collected whole blood samples from Nigeria. The acceptability and usability of DASH™ HCV will also be evaluated in real-world settings among at risk adults from three diverse geographic regions of Nigeria. This study is expected to lead to the approval of a small, portable, cheap POC molecular device for the rapid, single step, diagnosis of active HCV in a wide range of LMIC settings that will significantly increase availability and access to HCV testing and thus reduce the incidence of HCV- related HCC.

Project Narrative Active Viral Hepatitis Diagnostics to Support Prevention/Treatment of HCC Hepatocellular carcinoma (HCC) is a highly lethal cancer with over 80% of the cases occurring in low resource settings. Chronic hepatitis C (HCV) infection is major risk factor for HCC development. The goal of this proposal is to develop and validate a diagnostic test for HCV infections for use in low-and-middle-income-countries to identify patients for treatment thus reducing their risk of developing HCC.