Quality Assurance for Hepatitis C Virus Point-of-Care Diagnostics in Sub-Saharan 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.

Keywords

• REASSURED
• evaluation
• regulatory standards
• HCV
• POC testing
• SSA