Quality assurance for hepatitis C virus point-of-care diagnostics in sub-Saharan Africa
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Date
Authors
Duah, Evans
Mathebula, Evans Mantiri
Mashamba‑Thompson, Tivani Phosa
Journal Title
Journal ISSN
Volume Title
Publisher
MDPI
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.
Description
Keywords
Evaluation, Regulatory standards, Hepatitis C virus (HCV), Point-of-care (POC), Sub-Saharan Africa (SSA), REASSURED criteria, SDG-03: Good health and well-being
Sustainable Development Goals
SDG-03:Good heatlh and well-being
Citation
Duah, E.; Mathebula, E.M.; Mashamba-Thompson, T. Quality
Assurance for Hepatitis C Virus Point-of-Care Diagnostics in Sub-Saharan Africa. Diagnostics 2023, 13, 684. https://DOI.org/10.3390/diagnostics13040684.