Duah Evans, Mathebula Evans Mantiri, Mashamba-Thompson Tivani
Faculty of Health Science, School of Health Systems and Public Health, University of Pretoria, Pretoria 0002, South Africa.
Diagnostics (Basel). 2023 Feb 12;13(4):684. doi: 10.3390/diagnostics13040684.
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.
作为一项评估撒哈拉以南非洲（SSA）地区Bioline丙型肝炎病毒（HCV）即时检测（POC）的跨国研究的一部分，本叙述性综述总结了用于验证和批准HCV临床诊断的监管标准和质量指标。此外，本综述还以REASSURED标准为基准，总结了它们的诊断评估及其对世界卫生组织2030年HCV消除目标的影响。
