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Quality Assurance for Hepatitis C Virus Point-of-Care Diagnostics in Sub-Saharan Africa
Evans Duah1, Evans Mantiri Mathebula1, Tivani Mashamba-Thompson1
1Faculty of Health Science, School of Health Systems and Public Health, University of Pretoria, Pretoria 0002, South Africa.
Abstract:
As part of a multinational study to evaluate the Bioline Hepatitis C virus (HCV) point-of-care (POC) testing in sub-Saharan Africa (SSA), this narrative review summarises regulatory standards and quality indicators for validating and approving HCV clinical diagnostics. In addition, this review also provides a summary of their diagnostic evaluations using the REASSURED criteria as the benchmark and its implications on the WHO HCV elimination goals 2030.

