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.