Active Viral Hepatitis Diagnostics to Support Prevention/Treatment of HCC

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DESCRIPTION (provided by applicant): Active Viral Hepatitis Diagnostics to Support Prevention/Treatment of HCC Hepatocellular carcinoma (HCC) is very common in sub-Saharan Africa due to highly prevalent chronic hepatitis B (HBV) and hepatitis C (HCV) viral infection. Currently, patients in sub-Saharan Africa typically present in late stage disease, having a life expectancy of just three months. Earlier diagnosis could reduce HCC mortality in two ways: 1) patients with HBV or HCV would be staged earlier and tumors, if present, would be smaller and therefore easier to treat with alcohol ablation, the current standard of care in the region; and 2) patients identified earlier with chronic HBV or HCV could be treated with direct acting antiviral agents (DAAs) leading to reduced morbidity including less HCC. The goal of this application is to develop low cost point-of-care diagnostic tests to detect and monitor the treatment of active HBV and/or HCV infections. The first test to be developed will be an HCV core antigen qualitative test to identify patients with an active HCV infection. This assay will be ported on th LYNX immunoassay platform developed in collaboration with the Northwestern Global Health Foundation (NGHF). The test conditions developed for the LYNX p24 Antigen Rapid Lateral Flow Assay for Rapid Diagnosis of HIV Infection in Infants will be adapted to address a highly analogous problem: the detection of the HCV core antigen viral marker from plasma. The second test will be a multiplexed HBV/HCV viral load assay to determine when to initiate therapy and to monitor the viral response to DAA treatment. This assay will be ported onto the Savanna integrated nucleic acid extraction, amplification & detection system that is currently being developed in collaboration with the Quidel Corporation and NGHF. The test conditions developed for the Savanna RealTime HIV-1 Assay(R) will be used for the HBV/HCV viral load assay. Both the LYNX and the Savanna platforms have been designed for use in limited resource settings. They are inexpensive, easy to operate and robust. All reagents are provided with the test kits and no refrigeration is required. The analytical and clinical performance of these assays will be demonstrated in both laboratory and clinical validation studies at the Jos University Teaching Hospital in Jos, Nigeria. The tests will be transferred to their respective manufacturers, and regulatory approval for will be sought. The impact of earlier detection and improved monitoring of viral hepatitis will prompt earlier treatment resulting in prevention of carcinogenesis and/or earlier stage diagnosis with improved outcomes in patients in low and middle income countries.