Sample-to-Answer Detection of Hepatitis C Virus from Fingerstick Whole Blood via a Robust, Accessible Digital Microfluidic Device

Hepatitis C virus (HCV) infection remains a public health concern with approximately 2.4 million individuals infected in the U.S. and 58 million infected globally. Although effective direct acting antiviral therapies are available, their clinical impact has been limited by the lack of point-of-care tests to confirm viremic infection. Current HCV screening algorithms require a positive anti-HCV antibody test to be confirmed with a second test for HCV RNA. This approach reduces testing expenses but may fail to identify acute infection, individuals who have yet to seroconvert for anti-HCV antibodies, and recurrent infection. A point-of-care device for rapid and sensitive HCV RNA testing with a sample-to-answer workflow is needed to enable HCV diagnosis and linkage to care in a single provider visit. We propose a simplified sample-to-answer workflow to diagnose HCV infection on our point-of-care digital microfluidic platform, which will accept fingerstick capillary blood and sequentially prepare RNA, initiate HCV RNA target amplification, and detect real-time fluorescence measurements with no hands-on steps and minimal user training required. The platform will be suited for distributed outpatient settings (primary/urgent care facilities, community/mobile health clinics, or needle exchange programs) and will expedite HCV diagnosis and treatment while decreasing loss of care in susceptible populations.