Development and feasibility demonstration of a prototype rapid and accurate Lateral Flow Assay (LFA) to self-screen qualitatively for exposure to Hepatitis C Virus (HCV) in at-home settings, is proposed. The LFA, employing conserved immunogenic domains of proteins comprising the HCV human immunoproteome, will detect host antibody responses to such immunogenic protein domains in user-generated finger-prick blood samples. Preliminary validation / feasibility will be demonstrated using archived human serum specimens from patients clinically diagnosed to have had acute, chronic, or resolved HCV infection. The highly sensitive and specific assay will be simple enough for self-use, and output results that can be read visually by the end-user within 30 mins. It is anticipated that the resulting LFA will positively impact global public health by accurately identifying exposed individuals for further evaluation and contribute significantly to reducing HCV morbidity and mortality; hence, the LFA will be a valuable addition to the armamentarium of available tools for effective management of individuals with active HCV infection.
