Clinical Testing and Diagnosis for Hepatitis B

Key points

  • CDC published updated recommendations among adults for hepatitis B screening and testing in 2023 that are complementary to the 2022 Advisory Committee on Immunization Practices (ACIP) vaccine recommendations for hepatitis B.
  • The recommendations consider a simpler and less stigmatizing implementation strategy than previous risk-based hepatitis B virus (HBV) screening recommendations among adults.
A healthcare professional prepping a patient for medical testing

Why it’s important

More than half of people with hepatitis B are unaware of their infection status, and approximately 50%–70% of people with acute hepatitis B are asymptomatic1. Without testing, people with hepatitis B virus (HBV) infection can unknowingly transmit the virus to others.

Chronic HBV infection can lead to substantial morbidity and mortality but is detectable before the development of severe liver disease using reliable and inexpensive screening tests. Routine monitoring and treatment for chronic HBV infection can reduce morbidity and mortality, supporting the importance of early detection of HBV infection.

In addition, although not quantifiable, management of chronic infection through prevention efforts can prevent further transmission to others.

Read more on the rationale for the new recommendations.

For the public‎

For members of the general public looking for information on testing, see Hepatitis B Testing.

How to make decisions on whether to test or screen

Screening generally refers to serologic testing of asymptomatic people not known to be at increased risk for exposure to HBV.

Testing generally refers to serologic testing of people with symptoms or those who are at increased risk for exposure to HBV.

Adults

CDC recommends screening all adults aged 18 and older for hepatitis B at least once in their lifetime using a triple panel test. To ensure increased access to testing, anyone who requests HBV testing should receive it regardless of disclosure of risk. Many people might be reluctant to disclose stigmatizing risks.

Infants

CDC recommends testing all infants born to HBsAg-positive people for HBsAg and antibody to hepatitis B surface antigen (anti-HBs) seromarkers.

Pregnant people

CDC recommends HBV screening for HBsAg for all pregnant people during each pregnancy, preferably in the first trimester, regardless of vaccination status or history of testing. Pregnant people with a history of appropriately timed triple panel screening without subsequent risk for exposure to HBV (no new HBV exposures since triple panel screening) only need HBsAg screening.

People at increased risk

CDC recommends testing susceptible people periodically, regardless of age, with ongoing risk for exposures while risk for exposures persists. This includes:

  • People with a history of sexually transmitted infections or multiple sex partners.
  • People with history of past or current HCV infection.
  • People incarcerated or formerly incarcerated in a jail, prison, or other detention setting.
  • Infants born to HBsAg-positive people.
  • People born in regions with HBV infection prevalence of 2% or more.
  • US-born people not vaccinated as infants whose parents were born in geographic regions with HBsAg prevalence of 8% or more.
  • People who inject drugs or have a history of injection drug use.
  • People with human immunodeficiency virus (HIV) infection.
  • Men who have sex with men.
  • Household contacts or former household contacts of people with known HBV infection.
  • People who have shared needles with or engaged in sexual contact with people with known HBV infection.
  • People on maintenance dialysis, including in-center or home hemodialysis and peritoneal dialysis.
  • People with elevated liver enzymes.

Susceptible people include those who have never been infected with HBV and either did not complete a hepatitis B vaccine (HepB) series per ACIP recommendations or who are known to be vaccine nonresponders.

Keep Reading: Guidelines for Responding to Hepatitis B Exposures in Health Care Settings

Recommended tests

CDC now* recommends use of the triple panel test, which includes testing for:

  1. HBsAg
  2. Anti-HBs
  3. Total antibody to hepatitis B core antigen (total anti-HBc)

Any periodic follow-up testing can use tests as appropriate based on the results of the triple panel.

*Prior guidance recommended a single test of HBsAg.

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A flowchart illustrating the HBV screening and testing process into clinic workflows.
Incorporating HBV screening and testing into clinic workflow.

How to interpret test results

Different serologic markers or combinations of markers are used to identify different phases of HBV infection. They determine whether a patient has acute or chronic HBV infection, is immune to HBV as a result of prior infection or vaccination, or is susceptible to infection. Markers include:

  • HBsAg: HBsAg is a protein on the surface of HBV that can be detected in high levels in serum during acute or chronic HBV infection. The presence of HBsAg indicates that the person is infectious, except when it might be transiently positive within 30 days after a dose of HepB vaccine. The body normally produces antibodies to HBsAg as part of the normal immune response to infection. HBsAg is the antigen used to make HepB vaccine.
  • Anti-HBs: The presence of anti-HBs is generally interpreted as indicating recovery and immunity from HBV infection. Anti-HBs also develops in a person who has been successfully vaccinated against hepatitis B. Among vaccine responders who complete a vaccine series, anti-HBs levels can decline over time; however, the majority remain immune and will mount a response when exposed to HBV.
  • Anti-HBc: Anti-HBc appears at the onset of symptoms in acute hepatitis B, is a measure of both immunoglobulin M (IgM) and immunoglobulin G (IgG), and persists for life. The presence of total anti-HBc indicates previous or ongoing infection with HBV in an undefined time frame. People who have immunity to hepatitis B from a vaccine do not develop anti-HBc.
  • IgM anti-HBc: IgM anti-HBc positivity indicates recent infection with HBV (within less than 6 months). Its presence indicates acute infection. IgM anti-HBc should be ordered only when acute HBV infection is a concern.
Table 1: Interpretation of hepatitis B serologic test results
Test outcome Interpretation Action
HBsAg — Positive Total anti-HBc — Positive IgM anti-HBc — Positive Anti-HBs — Negative Acute infection Link to hepatitis B care
HBsAg — Positive Total anti-HBc — Positive IgM anti-HBc — Negative* Anti-HBs — Negative Chronic infection Link to hepatitis B care
HBsAg — Negative Total anti-HBc — Positive Anti-HBs — Positive Resolved infection Counsel about HBV infection reactivation risk
HBsAg — Negative Total anti-HBc — Negative Anti-HBs — Positive† Immune from receipt of prior vaccination (if documented complete series) If not vaccinated, then complete vaccine series
HBsAg — Negative Total anti-HBc — Positive Anti-HBs — Negative Only core antibody is positive. See possible interpretations and corresponding actions.
Resolved infection where anti-HBs levels have waned Counsel about HBV infection reactivation risk
Occult infection Link to hepatitis B care
Passive transfer of anti-HBc to an infant born to an HBsAg-positive gestational parent No action
False positive, thus patient is susceptible Offer HepB vaccine per ACIP
A mutant HBsAg strain that is not detectable by laboratory assay Link to hepatitis B care
HBsAg — Negative Total anti-HBc — Negative Anti-HBs — Negative‡ Susceptible, never infected (if no documentation of HepB vaccine series completion) Offer HepB vaccine per ACIP recommendations

Other resources

How to diagnose hepatitis B

The presence of the total anti-HBc antigen is needed to diagnose a patient with a hepatitis B infection. The results of the HBsAg, anti-HBs, and IgM anti-HBc tests indicate a patient’s type of hepatitis B and if they have developed immunity.

What to do next

CDC recommends that people who are diagnosed with hepatitis B be provided with:

  • Medical evaluation (by either a primary care clinician or specialist for chronic liver diseases) including treatment and monitoring.
  • Supportive care for their symptoms as needed.

For more CDC information on recommendations for testing, management, and treatment of hepatitis B, see Hepatitis B Clinical Care & Treatment.

Reporting cases

The National Notifiable Diseases Surveillance System (NNDSS) lists acute, chronic, and perinatal hepatitis B as nationally notifiable conditions.

You should report cases of suspected health care-associated HBV infection to state and local public health authorities for prompt investigation and response.

When you report a case, you will need an event code corresponding to the hepatitis B condition. You can reclassify cases if needed, as long as the changes occur before surveillance data are finalized each year.

National event codes:

  • Acute hepatitis B: 10100
  • Perinatal hepatitis B: 10104
  • Chronic hepatitis B: 10105

In 2024, The Council of State and Territorial Epidemiologists updated the surveillance case definitions for acute and chronic hepatitis B (HBV). These definitions are used to determine how to classify and report cases to the CDC. Surveillance data is in turn used to monitor trends in disease incidence, understand the burden of hepatitis B in the community, determine risk behaviors or exposures, identify outbreaks, and assess opportunities for prevention. For the most current guidance, see: Viral Hepatitis Surveillance and Case Management Guidance for State, Territorial, and Local Health Departments

Resources

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Division of Viral Hepatitis
  1. Kodani M, Schillie SF. Chapter 4: Hepatitis B. In: Roush S, Baldy LM, Kirkconnell Hall MA, eds. Manual for the Surveillance of Vaccine-Preventable Diseases, 2020.
  • * IgM anti-HBc also might be positive in persons with chronic infection during severe HBV infection flares or reactivation.
  • † Immune if anti-HBs concentration is >10 mIU/mL after vaccine series completion.
  • ‡ Anti-HBs concentrations might wane over time among vaccine responders. People with a documented, complete HepB vaccine series typically do not need to be revaccinated, except for special populations like patients on hemodialysis or health care personnel.