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

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...

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Detalles Bibliográficos
Autores principales: Duah, Evans, Mathebula, Evans Mantiri, Mashamba-Thompson, Tivani
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9955859/
https://www.ncbi.nlm.nih.gov/pubmed/36832172
http://dx.doi.org/10.3390/diagnostics13040684
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author Duah, Evans
Mathebula, Evans Mantiri
Mashamba-Thompson, Tivani
author_facet Duah, Evans
Mathebula, Evans Mantiri
Mashamba-Thompson, Tivani
author_sort Duah, Evans
collection PubMed
description 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.
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spelling pubmed-99558592023-02-25 Quality Assurance for Hepatitis C Virus Point-of-Care Diagnostics in Sub-Saharan Africa Duah, Evans Mathebula, Evans Mantiri Mashamba-Thompson, Tivani Diagnostics (Basel) Review 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. MDPI 2023-02-12 /pmc/articles/PMC9955859/ /pubmed/36832172 http://dx.doi.org/10.3390/diagnostics13040684 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Review
Duah, Evans
Mathebula, Evans Mantiri
Mashamba-Thompson, Tivani
Quality Assurance for Hepatitis C Virus Point-of-Care Diagnostics in Sub-Saharan Africa
title Quality Assurance for Hepatitis C Virus Point-of-Care Diagnostics in Sub-Saharan Africa
title_full Quality Assurance for Hepatitis C Virus Point-of-Care Diagnostics in Sub-Saharan Africa
title_fullStr Quality Assurance for Hepatitis C Virus Point-of-Care Diagnostics in Sub-Saharan Africa
title_full_unstemmed Quality Assurance for Hepatitis C Virus Point-of-Care Diagnostics in Sub-Saharan Africa
title_short Quality Assurance for Hepatitis C Virus Point-of-Care Diagnostics in Sub-Saharan Africa
title_sort quality assurance for hepatitis c virus point-of-care diagnostics in sub-saharan africa
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9955859/
https://www.ncbi.nlm.nih.gov/pubmed/36832172
http://dx.doi.org/10.3390/diagnostics13040684
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