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:
Review
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
Descripción
Sumario: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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