Burnet Institute, Melbourne, VIC 3004, Australia.
Department of Gastroenterology, St Vincent's Hospital, Fitzroy, VIC 3065, Australia.
Cells. 2020 Oct 2;9(10):2233. doi: 10.3390/cells9102233.
Despite the heavy disease burden posed by hepatitis B, around 90% of people living with hepatitis B are not diagnosed globally. Many of the affected populations still have limited or no access to essential blood tests for hepatitis B. Compared to conventional blood tests which heavily rely on centralised laboratory facilities, point-of-care testing for hepatitis B has the potential to broaden testing access in low-resource settings and to engage hard-to-reach populations. Few hepatitis B point-of-care tests have been ratified for clinical use by international and regional regulatory bodies, and countries have been slow to adopt point-of-care testing into hepatitis B programs. This review presents currently available point-of-care tests for hepatitis B and their roles in the care cascade, reviewing evidence for testing performance, utility, acceptability, costs and cost-effectiveness when integrated into hepatitis B diagnosis and monitoring programs. We further discuss challenges and future directions in aspects of technology, implementation, and regulation when adopting point-of-care testing in hepatitis B programs.
尽管乙型肝炎带来了沉重的疾病负担,但在全球范围内,仍有约 90%的乙型肝炎感染者未被诊断出来。许多受影响的人群仍然无法获得或只能有限地获得乙型肝炎基本血液检测。与严重依赖中心化实验室设施的传统血液检测相比,乙型肝炎即时检测有可能扩大在资源匮乏环境中的检测机会,并接触难以接触到的人群。少数乙型肝炎即时检测已获得国际和地区监管机构的临床使用批准,而且各国将即时检测纳入乙型肝炎规划的速度缓慢。本综述介绍了目前可用的乙型肝炎即时检测及其在护理链中的作用,综述了将其纳入乙型肝炎诊断和监测规划时在检测性能、实用性、可接受性、成本和成本效益方面的证据。我们还进一步讨论了在乙型肝炎规划中采用即时检测时在技术、实施和监管方面的挑战和未来方向。