Rapid point-of-care molecular test for HCV VL

ABSTRACT Chronic hepatitis C virus (HCV) infection is a hidden public health problem, due to ineffective disease testing and surveillance strategies. Testing for HCV is two-step, with patients initially screened for HCV antibodies, followed with an RNA viral load (VL) test at a subsequent visit. However, follow up rates are low due to the time it takes to obtain results and the need for multiple visits for treatment. Point of care (POC) testing is vital for disease surveillance of chronic infections like HCV, as these tests can be performed in a single visit and decrease treatment initiation time. Current HCV POC VL testing platforms do not meet the global stakeholder-generated target product profile to identify active HCV infection. An additional barrier to HCV testing is sample preparation, which is laborious, time consuming, prone to human error, and expensive. Thus, we believe the correct strategy for HCV POC VL testing is a low-cost, automated platform that performs HCV isolation utilizing gold-standard magnetic bead-based protocols, for shorter time to results, greater sensitivity, and a lower limit of detection. This strategy will allow for more widespread and accurate HCV community testing and surveillance, reducing hands-on time and operator burden, as well as the global healthcare burden of HCV infection. This Phase II project will implement sample-to-answer HCV POC VL testing by building on our automated sample preparation platform and successful Phase I development of an RPA isothermal assay for HCV detection.