FAQs: Screening and Testing

FAQs: Screening and Testing

​​​​​FAQs: Screening and Testing

What guidance is available on testing strategies for hepatitis B and C viruses?

WHO has developed Guidelines on Hepatitis B and C Testing. This document outlines various hepatitis B and hepatitis C testing approaches and service delivery settings and the benefits and harms to each approach/setting.

The WHO Global Health Sector Strategy on Viral Hepatitis 2016-2021[LJC1]  calls for a major increase in diagnosis of chronic viral B and C infection, with 30% of people infected knowing their status by 2020 and 90% by 2030. The strategy calls for countries to:

  • Integrate viral hepatitis testing into national hepatitis policies and guidelines that defines, among other things, priority populations and locations for testing, testing approaches and strategies. 
  • Strengthen the national laboratory system to provide quality diagnosis of acute and chronic hepatitis with timely reporting of results and ensure the reliable supply of quality-assured (WHO prequalified) diagnostics. 
  • Establish key linkages between testing and other services to improve referral and access to quality- assured treatment and other support services. 

The World Hepatitis Alliance’s global campaign – Find the Missing Millions – is a three-year global awareness-raising and advocacy campaign aimed at tackling the main barriers to diagnosis by putting civil society organizations and the affected community at the heart of the solution.

The ECDC conducted a systematic review and has developed a technical report on Hepatitis B and C testing strategies in healthcare and community settings in the EU/EEA. This report reviews the effectiveness of testing initiatives in primary healthcare settings, hospital settings, other healthcare settings, community settings and multiple/unspecified settings. 

The ECDC has also developed a Public health guidance on HIV, hepatitis B and C testing in the EU/EEA and provides in-depth guidance on which populations to test, how to conduct the testing, what settings to consider, and what strategic information is needed.

Australia provides a list of populations to consider testing for HCV as part of their Australian recommendations for the management of hepatitis C virus infection: a consensus statement.

The Boston Consulting Group developed the Road to Elimination: Barriers and Best Practices in Hepatitis C Management Overview of the status of HCV care in Europe and Australia.

The Coalition for Global Hepatitis Elimination includes hepatitis action plans in their evidence base. The database includes more than 100 regional, country and local action plans can be used as a model for countries and programs developing a hepatitis action plan. The following countries and regions have included hepatitis screening strategies in their country plans:

The following articles have been published on this topic:

Assessing the Effectiveness of Strategies in US Birth Cohort Screening for Hepatitis C InfectionThis article reviews various strategies for increasing HCV birth cohort screening in the United States.

What testing is recommended for diagnosing HBV infection?

The WHO Guidelines on hepatitis B and C testing [LJC1] recommends for the diagnosis of chronic HBV infection in adults, adolescents and children (>12 months of age1), a serological assay (in either RDT or laboratory-based immunoassay format2) that meets minimum quality, safety and performance standards3 (with regard to both analytical and clinical sensitivity and specificity) is recommended to detect hepatitis B surface antigen (HBsAg). 

  • In settings where existing laboratory testing is already available and accessible, laboratory-based immunoassays are recommended as the preferred assay format. 
  • In settings where there is limited access to laboratory testing and/or in populations where access to rapid testing would facilitate linkage to care and treatment, use of RDTs is recommended to improve access. 
    • [1] A full vaccination schedule including birth dose should be completed in all infants in accordance with the WHO position paper on Hepatitis B vaccines, 2009. Testing of exposed infants is problematic within the first six months of life as HBsAg and hepatitis B DNA may be inconsistently detectable in infected infants. Exposed infants should be tested for HBsAg between 6 and 12 months of age to screen for evidence of hepatitis B infection. In all age groups, acute HBV infection can be confirmed by the presence of HBsAg and IgM anti-HBc. CHB is diagnosed if there is persistence of HBsAg for six months or more. 
    • [2] Laboratory-based immunoassays include enzyme immunoassay (EIA), chemoluminescence immunoassay (CLIA), and electrochemoluminescence assay (ECL). 

The US CDC Recommendations for Identification and Public Health Management of Persons with Chronic Hepatitis B Virus Infection recommend testing for hepatitis B virus using a serologic assay for HBsAg offered as a part of routine care and be accompanied by appropriate counseling and referral for recommended clinical evaluation and care. Laboratories that provide HBsAg testing should use an FDA-licensed or FDA-approved HBsAg test and should perform testing according to the manufacturer's labeling, including testing of initially reactive specimens with a licensed, neutralizing confirmatory test. 

The ECDC has developed a Public health guidance on HIV, hepatitis B and C testing in the EU/EEA and provides in-depth guidance on which populations to test and how to conduct the testing.

The AASLD Guidelines for Treatment of Chronic Hepatitis B includes a section on testing for hepatitis B infection.

APASL has developed the Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update which includes a section on testing for hepatitis B infection.

What testing is required for diagnosing HCV infection?

The WHO Guidelines on hepatitis B and C testing [LJC1] [LJC2] recommend to test for serological evidence of past or present HCV infection in adults, adolescents and children (>18 months of age1), an HCV serological assay (antibody or antibody/antigen) using either RDT or laboratory-based immunoassay formats2 that meet minimum safety, quality and performance standards3 (with regard to both analytical and clinical sensitivity and specificity) is recommended. 

  • In settings where there is limited access to laboratory infrastructure and testing, and/or in populations where access to rapid testing would facilitate linkage to care and treatment, RDTs are recommended. 
    • [1] HCV infection can be confirmed in children under 18 months only by virological assays to detect HCV RNA, because transplacental maternal antibodies remain in the child’s bloodstream up until 18 months of age, making test results from serology assays ambiguous
    • [2] Laboratory-based immunoassays include enzyme immunoassay (EIA), chemoluminescence immunoassay (CLIA), and electrochemoluminescence assay (ECL).
    • [3] Assays should meet minimum acceptance criteria of either WHO prequalification of IVDs or a stringent regulatory review for IVDs. All IVDs should be used in accordance with manufacturers’ instructions, and where possible at testing sites enrolled in a national or international external quality assessment scheme. A lower level of analytical sensitivity can be considered, if an assay is able to improve access (i.e. an assay that can be used at the point of care or suitable for dried blood spot [DBS] specimens) and/or affordability. An assay with a limit of detection of 3000 IU/mL or lower would be acceptable and would identify 95% of those with viraemic infection, based on available data. 

The US CDC recommends hepatitis C testing be initiated with a Food and Drug Administration (FDA)‑approved anti‑HCV test. People testing anti‑HCV positive/reactive should have follow-up testing with an FDA‑approved nucleic acid test (NAT) for detection of HCV RNA.

AASLD and IDSA have developed the HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C

APASL has developed the APASL consensus statements and recommendations for hepatitis C prevention, epidemiology, and laboratory testing

The following articles have been published on this topic:

Methodological challenges in appraising evidence on diagnostic testing for WHO guidelines on hepatitis B and hepatitis C virus infectionThis article summarizes methodological challenges and additional considerations encountered in applying these procedures to diagnostic testing for viral hepatitis, and strategies to address these.

​​​​​​​What are different options for screening policies?

Testing recommendations for HBV and HCV are outlined in WHO’s Guidelines on Hepatitis B and C Testing. The guide makes the following recommendations:

Countries may consider testing for HBV in the following ways:

  • General population testing

  • Routine testing of pregnant women

  • Focused risk-based testing in populations with high-risk behavior or exposure to HBV infection

  • Couples and partner testing in ANC

  • Screening blood donors

Countries may consider testing for HCV in the following ways:

  • Focused risk-based testing in the most affected populations

  • General population testing

  • Birth cohort testing

In what settings can HCV tests be delivered?

HCV tests can be administered in primary health care settings, hospital settings, community settings (e.g. targeting groups such as drug users, homeless people, migrants, men who have sex with men (MSM) and underprivileged people),  and other types of settings such as: antenatal services, clinics for people with no health insurance, drug services (embedded in health services), migrant clinics, pharmacies, prisons, public health clinics and STI clinics.

The ECDC conducted a systematic review and has developed a technical report on Hepatitis B and C testing strategies in healthcare and community settings in the EU/EEA which reviews the effectiveness of testing initiatives in various settings.

What are the costs of HCV testing?

The CHAI Hepatitis C Market Report provides an overview of the supplier landscape for WHO prequalified/Expert Review Panel reviewed HCV treatment drugs and diagnostics, outline historical volumes and pricing trends, highlight global benchmark prices, and suggest potential ways in which countries can access diagnostics and drugs at more affordable prices.

Do you have any opinion/perspective on HBV diagnostics utilizing biomarkers based on direct RNA sequencing (as previous studies suggested different types of RNA being present in serum) to identify different stages of HBV on patients?

Answer: Different HBV tests are used to detect new (acute) from chronic infection and to monitor indications and response to treatment. Virologic tests to detect and quantify HBV DNA are essential in detecting HBV infection early in the course of disease (e.g., blood bank screening) and based on the viral load guide treatment decisions, assess responses to treatment, and determine risk of HBV-related complications. There are now multiple efforts underway to discover “functional cures” for HBV infection. New tests are proposed to monitor the response to new therapies.  

A recent review is available:

New and Old Biomarkers for Diagnosis and Management of Chronic HBV Infection

This question came from the NIH webinar series

Are there any prequalified HBeAg rapid diagnostic tests in the market?

There are currently no HBeAg rapid diagnostic tests on the WHO list of prequalified in vitro diagnostic products.

Last day updated 03 Mar 2022