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WHO Guidelines on Hepatitis B and C Testing. Geneva: World Health Organization; 2017 Feb.

Cover of WHO Guidelines on Hepatitis B and C Testing

WHO Guidelines on Hepatitis B and C Testing.

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6WHO TO TEST FOR CHRONIC HEPATITIS B OR C INFECTION – testing approaches and service delivery

6.1. Recommendations

WHO TO TEST FOR CHRONIC HBV INFECTION
Testing approach and populationRecommendations*
General population testing
  1. In settings with a ≥2% or ≥5%1 HBsAg seroprevalence in the general population, it is recommended that all adults have routine access to and be offered HBsAg serological testing with linkage to prevention, care and treatment services.
    General population testing approaches should make use of existing community- or health facility-based testing opportunities or programmes such as at antenatal clinics, HIV or TB clinics.
    Conditional recommendation, low quality of evidence
Routine testing in pregnant women
2.

In settings with a ≥2% or ≥5%%1 HBsAg seroprevalence in the general population, it is recommended that HBsAg serological testing be routinely offered to all pregnant women in antenatal clinics2, with linkage to prevention, care and treatment services. Couples and partners in antenatal care settings should be offered HBV testing services.

Strong recommendation, low quality of evidence

Focused testing in most affected populations
3.

In all settings (and regardless of whether delivered through facility- or community-based testing), it is recommended that HBsAg serological testing and linkage to care and treatment services be offered to the following individuals:

  • Adults and adolescents from populations most affected by HBV infection3 (i.e. who are either part of a population with high HBV seroprevalence or who have a history of exposure and/or high-risk behaviours for HBV infection);
  • Adults, adolescents and children with a clinical suspicion of chronic viral hepatitis4 (i.e. symptoms, signs, laboratory markers);
  • Sexual partners, children and other family members, and close household contacts of those with HBV infection5;
  • Health-care workers: in all settings, it is recommended that HBsAg serological testing be offered and hepatitis B vaccination given to all health-care workers who have not been vaccinated previously (adapted from existing guidance on hepatitis B vaccination6)

Strong recommendation, low quality of evidence

Blood donors
Adapted from existing 2010 WHO guidance (Screening donated blood for transfusion transmissible infections7)
4.

In all settings, screening of blood donors should be mandatory with linkage to care, counselling and treatment for those who test positive.

Abbreviations: HBsAg: hepatitis B surface antigen; PWID: people who inject drugs; MSM: men who have sex with men

*

The GRADE system (Grading of Recommendations, Assessment, Development and Evaluation) was used to categorize the strength of recommendations as strong or conditional (based on consideration of the quality of evidence, balance of benefits and harms, acceptability, resource use and programmatic feasibility) and the quality of evidence as high, moderate, low or very low.

1

A threshold of ≥2% or ≥5% seroprevalence was based on several published thresholds of intermediate or high seroprevalence. The threshold used will depend on other country considerations and epidemiological context.

2

Many countries have chosen to adopt routine testing in all pregnant women, regardless of seroprevalence in the general population, and particularly where seroprevalence ≥2%. A full vaccination schedule including birth dose should be completed in all infants, in accordance with the WHO position paper on hepatitis B vaccines 2009.6

3

Includes those who are either part of a population with higher seroprevalence (e.g. some mobile/migrant populations from high/intermediate endemic countries, and certain indigenous populations) or who have a history of exposure or high-risk behaviours for HBV infection (e.g. PWID, people in prisons and other closed settings, MSM and sex workers, HIV-infected persons, partners, family members and children of HBV-infected persons).

4

Features that may indicate underlying chronic HBV infection include clinical evidence of existing liver disease, such as cirrhosis or hepatocellular carcinoma (HCC), or where there is unexplained liver disease, including abnormal liver function tests or liver ultrasound.

5

In all settings, it is recommended that HBsAg serological testing with hepatitis B vaccination of those who are HBsAg negative and not previously vaccinated be offered to all children with parents or siblings diagnosed with HBV infection or with clinical suspicion of hepatitis, through community- or facility-based testing.

6

WHO position paper. Hepatitis B vaccines. Wkly Epidemiol Rec. 2009;4 (84):405–20.

7

Screening donated blood for transfusion transmissible infections. Geneva: World Health Organization; 2010. [PubMed: 23741773]

WHO TO TEST FOR CHRONIC HCV INFECTION
Testing approach and populationRecommendations*
Focused testing in most affected populations
  1. In all settings (and regardless of whether delivered through facility- or community-based testing), it is recommended that serological testing for HCV antibody (anti-HCV)1 be offered with linkage to prevention, care and treatment services to the following individuals:
    • Adults and adolescents from populations most affected by HCV infection2 (i.e. who are either part of a population with high HCV seroprevalence or who have a history of exposure and/or high-risk behaviours for HCV infection);
    • Adults, adolescents and children with a clinical suspicion of chronic viral hepatitis3 (i.e. symptoms, signs, laboratory markers).
    Strong recommendation, low quality of evidence
Note: Periodic re-testing using HCV NAT should be considered for those with ongoing risk of acquisition or reinfection.
General population testing
2.

In settings with a ≥2% or ≥5%4 HCV antibody seroprevalence in the general population, it is recommended that all adults have access to and be offered HCV serological testing with linkage to prevention, care and treatment services.

General population testing approaches should make use of existing community- or facility-based testing opportunities or programmes such as HIV or TB clinics, drug treatment services and antenatal clinics5.

Conditional recommendation, low quality of evidence

Birth cohort testing
3.

This approach may be applied to specific identified birth cohorts of older persons at higher risk of infection6 and morbidity within populations that have an overall lower general prevalence.

Conditional recommendation, low quality of evidence

Abbreviations: NAT: nucleic acid test; anti-HCV: HCV antibody; PWID: people who inject drugs; MSM: men who have sex with men

*

The GRADE system (Grading of Recommendations, Assessment, Development and Evaluation) was used to categorize the strength of recommendations as strong or conditional (based on consideration of the quality of evidence, balance of benefits and harms, acceptability, resource use and programmatic feasibility) and the quality of evidence as high, moderate, low or very low.

1

This may include fourth-generation combined antibody/antigen assays

2

Includes those who are either part of a population with higher seroprevalence (e.g. some mobile/migrant populations from high/intermediate endemic countries, and certain indigenous populations) or who have a history of exposure or high-risk behaviours for HCV infection (e.g. PWID, people in prisons and other closed settings, MSM and sex workers, and HIV-infected persons, children of mothers with chronic HCV infection especially if HIV-coinfected).

3

Features that may indicate underlying chronic HCV infection include clinical evidence of existing liver disease, such as cirrhosis or hepatocellular carcinoma (HCC), or where there is unexplained liver disease, including abnormal liver function tests or liver ultrasound.

4

A threshold of ≥2% or ≥5% seroprevalence was based on several published thresholds of intermediate and high seroprevalence. The threshold used will depend on other country considerations and epidemiological context.

5

Routine testing of pregnant women for HCV infection is currently not recommended.

6

Because of historical exposure to unscreened or inadequately screened blood products and/or poor injection safety.

6.2. Background

Viral hepatitis testing can be delivered to different populations and in different settings as part of general population testing, and/or a focused testing approach in most affected or high-risk populations, delivered through either health facility-based or community-based testing. Chapter 17 provides additional details on the different facility- and community-based testing approaches available. Chapter 18 provides additional guidance on testing in specific populations.

Different hepatitis testing approaches

There are several possible approaches to testing for HBV and HCV infection.

  1. General population testing. This approach refers to routine testing throughout the entire population without attempting to identify high-risk behaviours or characteristics. It means that all members of the population should have potential access to the testing services. This approach might be indicated for those countries with an intermediate or high HBV or HCV seroprevalence. At present, only Japan recommends HCV testing for all individuals once in their lives regardless of demographics or specific behavioural risk.
  2. Focused or targeted testing of specific high-risk groups. This approach refers to testing of specific populations who are most affected by hepatitis B or C infection, either because they are part of a population with high HBV or HCV seroprevalence (such as some migrant populations and some indigenous populations), or have a high risk of acquisition because of risk behaviours and/or exposures. This includes PWID, people in prisons and other closed settings, MSM and sex workers, HIV-infected persons, partners or family members of infected persons, and health-care workers. It may also involve testing on the basis of clinical suspicion of viral hepatitis (i.e. symptoms, signs or abnormal liver function tests or ultrasound scan).
  3. Routine antenatal clinic (ANC) testing. This means routine testing of pregnant women especially in settings where there is an intermediate or high seroprevalence, to identify women in need of antiviral treatment for their own health and additional interventions to reduce MTCT of viral hepatitis.
  4. “Birth cohort” testing. This approach means routine testing among easily identified age or demographic groups (i.e. specific “birth cohorts”) known to have high HCV prevalence due to past generalized exposures that have since been identified and removed. General one-time screening among this population avoids the need to identify risk behaviour. Most countries have at least some component of a “birth cohort” epidemic profile for HCV. Use of a birth cohort approach to HCV testing is currently recommended only in the United States.
  5. Blood donor screening. WHO already recommends universal blood donor screening for viral hepatitis in order to prevent transmission of bloodborne viruses to the recipient (20). However, at present, this is rarely accompanied by the HBsAg- or HCV antibody -positive donors being informed of this positive result, counselled and linked to care for clinical evaluation and treatment (141).

Service delivery of testing approaches (health facility- or community-based)

The testing approaches described above can be offered and delivered using both health-facility and/or community-based testing services.

Health-facility-based testing includes primary care clinics, inpatient wards and outpatient clinics, including specialist dedicated clinics such as HIV, STI and TB clinics, in district and provincial or regional hospitals as well as their laboratories, and in private clinical services.

Community-based testing can be offered and delivered using outreach (mobile) approaches in general and key populations; home-based testing (or door-to-door outreach); testing in workplaces, places of worship, parks, bars and other venues; in schools and other educational establishments; as well as through campaigns (e.g. screening for HIV or malaria alongside that for noncommunicable diseases such as diabetes and hypertension). Although many of these approaches were developed to increase the coverage and impact of HIV testing (11), they are equally applicable to the delivery of hepatitis testing.

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