Development of a Rapid Automated Point-of-Care Test for Hepatitis C Viral RNA on the DASH Rapid Polymerase Chain Reaction System

BACKGROUND: Hepatitis C virus (HCV) infection is a major public health problem despite the availability of highly effective and curative direct-acting antiviral treatments. Low diagnostic rates, driven in part by a 2-step diagnostic process and the need for molecular confirmation, pose a significant barrier to timely treatment. Here we describe the development, analytical characterization, and a preliminary clinical validation study of a rapid, user-friendly, sensitive, qualitative molecular test for point-of-care HCV testing. METHODS: This study evaluated the analytical performance of a 15-minute time to result qualitative molecular test for HCV on the sample-to-answer point-of-care DASH Rapid PCR System. The dynamic range, limit of detection, analytical specificity, and the equivalent detection of genotypes 1-6 were assessed. A small clinical validation study was independently conducted by Johns Hopkins University investigators using retrospectively collected specimens. RESULTS: The Research Use Only DASH HCV assay has wide dynamic range, can detect HCV genotypes 1-6, and has a detection limit of 200 IU/mL with 100 μL specimen volume addition. In a preliminary study of 97 plasma specimens, the DASH HCV assay demonstrated 100% positive percent agreement and 100% negative percent agreement when compared to commercial platforms. CONCLUSIONS: The DASH HCV test holds potential to enable same-day diagnosis and treatment in support of HCV elimination efforts.