Testing & Diagnostics
WHO estimates that in 2022, 254 million people were living with chronic hepatitis B virus infection, and 50 million people with chronic hepatitis C virus infection. Globally, these infections are major causes of acute and chronic liver disease, causing an estimated 1.3 million deaths annually, mostly from cirrhosis and hepatocellular carcinoma, an increase from 1.1 million deaths in 2019 (read more: Global hepatitis report 2024).
Testing is an essential entry point in accessing hepatitis B and C prevention, care and treatment services, making it a critical component of national responses. Despite the high global burden of disease due to chronic viral hepatitis, as well as advances and opportunities for treatment, most people infected with hepatitis B and/or C virus remain unaware of their infection. Therefore, these people frequently present with advanced disease and may transmit the infection to others. By the end of 2022, only 13% of the estimated 254 million people living with hepatitis B had been diagnosed, and less than 3% had received antiviral treatment. Of the estimated 50 million people living with hepatitis C, 36% had been diagnosed between 2015 and 2022, and 20% had received curative treatment.
Demand creation and awareness raising, cost-effective testing strategies and active case-finding and testing allow early identification of people with chronic hepatitis B and C. This enables people to receive the necessary care and treatment to prevent or delay progression of liver disease. Testing also provides an opportunity to link people to prevention interventions to reduce transmission, notably with regards to safe health-care injections, blood safety, hepatitis B vaccination and harm reduction services.
Viral hepatitis testing services should be included in national essential health benefit packages, supported by adequate financing and coordinated actions to advance universal health coverage and integration in primary health care.
Normative guidance
In its normative and standard-setting work, WHO is an evidence-based organization with a focus on public health. Ongoing reviews of studies and evidence in hepatitis, syphilis and HIV testing and diagnostics have resulted in recent guidelines. Adopting and adapting these recommendations will support improved access, services and care towards national hepatitis prevention and treatment goals.
In 2024, WHO published an operational guide on priorities in planning hepatitis B and C testing services. The purpose of this guide is to support countries in developing policies and practices that define a strategic mix of hepatitis B and C testing approaches. This guide consolidates key WHO recommendations from diverse WHO guidelines.
Priorities in planning person-centred hepatitis B and C testing services: operational guide
This operational guide on viral hepatitis testing services provides support to countries in developing policies and practices that define a strategic...
Guidelines for the prevention, diagnosis, care and treatment for people with chronic hepatitis B infection
Hepatitis B (HBV) infection is a major public health problem and cause of chronic liver disease. The 2024 HBV guidelines provide updated evidence-informed...
Updated recommendations on treatment of adolescents and children with chronic HCV infection, and HCV...
Hepatitis C virus (HCV) infection is a major public health problem and cause of chronic liver disease that leads to approximately 399 000 deaths annually....
Updated recommendations on treatment of adolescents and children with chronic HCV infection
This policy brief focuses on the new recommendations on treatment of adolescents and children aged 3 years or older with chronic hepatitis C virus (HCV)...
Updated recommendations on simplified service delivery and diagnostics for hepatitis C infection
This policy brief, one of two on the updated hepatitis C (HCV) guidelines, focuses on the new recommendations on simplified service delivery for a public...
WHO has set a global goal to eliminate HCV as a public health problem by 2030. WHO estimates that 58 million people had chronic hepatitis C virus (HCV)...
Guidelines on hepatitis B and C testing
Hepatitis B virus (HBV) and hepatitis C virus (HCV) infection are major causes of acute and chronic liver disease (e.g. cirrhosis and hepatocellular carcinoma) globally,...
Guidelines on hepatitis B and C testing
These are the first WHO guidelines on testing for chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infection and complement published guidance...
Technologies
Currently serological tests and molecular tests are available for the diagnosis of both hepatitis B and C infections.
WHO’s Guidelines on hepatitis B and C testing recommend that serological assays – using either rapid diagnostic test or enzyme immunoassay – can be used for initial testing.
Furthermore, WHO recommends since 2021 the use of HCV self-tests as an additional approach to HCV testing services.
Molecular tests to detect and quantify HCV RNA or HBV DNA are recommended after detection of serological markers. WHO recommends as well the use of point-of-care solution for molecular testing as an alternative approach to laboratory-based testing.
WHO recommends that all assays should meet minimum quality, safety and performance standards.
To drive innovation and disseminate information, key WHO activities can support national and international uptake, scale-up and utilization of hepatitis testing and diagnostic technologies. These include target product profiles, technology landscapes, and information on novel and innovative technologies.
A target product profile outlines the desired “profile” or characteristics of a target product for a particular disease or condition. Target product profiles state intended use, target populations and other desired attributes of products, including safety and efficacy-related characteristics. Such profiles should guide funders and developers in product research and development as market indications of country needs.
Technology landscapes provide details and information on the variety of products available for a particular disease or condition. While it is challenging to be completely exhaustive, technology landscapes generally provide the availability and market considerations for a range of technologies. They are often created by WHO and/or partners.
More information
Regulatory
WHO Prequalification of In Vitro Diagnostics is coordinated through the Department of Essential Medicines and Health Products. Focus is placed on in vitro diagnostics for priority diseases and their suitability for use in resource-limited settings. This service has been provided by WHO since 2001 to facilitate access to medicines and diagnostics that meet unified standards of quality, safety and efficacy/performance.
Large-scale roll-outs of hepatitis B and C diagnostics and treatment in low- and middle-income countries must be accompanied by efforts to ensure compliance with international quality assurance standards and national regulatory procedures. The availability of quality-assured diagnostics and generic products is steadily increasing, offering a tremendous opportunity to scale up access to diagnosis and treatments that are reliable and safe. On the other hand, a large number of unregulated rapid diagnostic tests for hepatitis B and C virus are also available for purchase at low prices through popular e-commerce websites. Product registration and quality assurance are therefore critical to ensure service quality.
For countries that do not currently possess capacity and/or competency to regulate in vitro diagnostics and other laboratory equipment and items, the WHO prequalification assessment serves as a mechanism to provide an independent assessment of the quality, safety and performance of in vitro diagnostics that are intended for sale and use in resource-limited settings.
Post-market surveillance is a set of activities conducted by manufacturers to collect and evaluate experiences with medical devices that have been placed on the market, and to identify the need for any action. Post-market surveillance is crucial to ensure that medical devices continue to be safe and well-performing, and to ensure action is taken if the risk of continued use outweighs the benefit. The evaluation of post-market surveillance experiences can also highlight opportunities to improve the medical device.