Abstract

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.

Highlights

  • More than 257 million people, or 3.2% of the world’s population, are estimated to be living with chronic hepatitis B virus infection, with the greatest disease burden in low-resource countries in theAsia-Pacific and sub-Saharan Africa [1]

  • For people who are already living with hepatitis B, receiving early diagnosis and clinical care is the key to reducing morbidity and mortality

  • We describe future technologies and explore how Point-of-care tests (POCs) tests might best be used to achieve World HealthOrganization (WHO) 2030 hepatitis B elimination goals

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Summary

Introduction

More than 257 million people, or 3.2% of the world’s population, are estimated to be living with chronic hepatitis B virus infection, with the greatest disease burden in low-resource countries in the. The requirement for lifelong monitoring for most people living with hepatitis B that involves regular blood tests [4,5], combined with barriers to timely healthcare access such as hepatitis B-related stigma [18,19], healthcare costs for users and providers [20] and the logistics of accessing consistent, high-quality, affordable healthcare services in a timely manner are major barriers for people to receive guideline-based care [16] These barriers lead to significant attrition from every step of the hepatitis B care cascade over time, and those lost from care represent missed opportunities for treatment and liver cancer prevention [16,21]. We describe future technologies and explore how POC tests might best be used to achieve WHO 2030 hepatitis B elimination goals

POC Tests for Hepatitis B and Their Clinical Performance
Diagnosis of Current Hepatitis B Infection
Diagnosis of Hepatitis B Immunity
Chronic Hepatitis B Care
Hepatitis B DNA Quantification
Novel Biomarkers
ALT and Assessment of Liver Fibrosis
Dried Blood Spot
Cost-Effectiveness of Using POCs for Hepatitis B
Utility and Acceptability of POCs for Hepatitis B
Limitations
Technology Needs
Implementation Approach
Regulatory Approval
Findings
Conclusions
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