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Review
. 2023 Feb 12;13(4):684.
doi: 10.3390/diagnostics13040684.

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

Evans Duah  1 , Evans Mantiri Mathebula  1 , Tivani Mashamba-Thompson  1
Affiliations
Review

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

Evans Duah et al. Diagnostics (Basel). .

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: HCV; POC testing; REASSURED; SSA; evaluation; regulatory standards.

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Conflict of interest statement

The authors declare no conflict of interest.

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