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HBV Triple Screen Panel with Reflexes

Test Code(s) 39170

The Hepatitis B Virus (HBV) Screen Panel with Reflexes includes test components that allow for initial laboratory evaluation of HBV status for several different patient populations, including patients with acute, chronic or vaccinated immunity to hepatitis B.1,2 The panel components include:

  • Hepatitis B Surface Antigen (HBsAg) with Reflex Confirmation (test code 498)
  • Hepatitis B Core Antibody (HBcAb), Total, with Reflex to IgM (test code 37676)*
  • Hepatitis B Surface Antibody (HBsAb) Immunity, Quantitative (8475)

* Hepatitis B Core Antibody, Total (test code 501[X]) is a measure of both IgM and IgG antibodies to hepatitis B core antigen (HBcAg), for which there is no direct antigen test. The test does not distinguish between IgG and IgM antibodies. HBcAb may be detected before or at the onset of symptoms; however, such reactivity can persist for years after illness, and may even outlast HBsAb. Occasionally HBcAb may be the only marker of either current or past hepatitis B infection. HBV vaccination leads to development of HBsAb but not to HBcAb.

An evaluation of the combination of results from these tests permits initial assessment of the patient’s overall hepatitis B status. The laboratory report also provides an overall interpretation of the panel of hepatitis B results.

This Panel was created to simplify the hepatitis B screening process; the component tests in the Panel are adapted from recommendations from the American Association for the Study of Liver Disease (AASLD) and the US Centers for Disease Control and Prevention (CDC).1,2

The CDC estimated that hepatitis B has been diagnosed in only 15% of individuals with acute hepatitis B infection.3 Testing asymptomatic individuals who are at risk for HBV infection can identify those with hepatitis B, allowing them to be directed to appropriate medical follow-up and reducing further spread of infection.2

Accordingly, in March 2023, the CDC issued updated recommendations. The CDC recommends all 3 tests in the Hepatitis B Virus (HBV) Screen Panel at least once per lifetime for all adults (ages 18 years and older).2  Beyond a once-per-lifetime screen, the panel is useful for patients at increased risk of HBV infection.2 The updated CDC report expands risk-based testing recommendations to include the following populations, activities, exposures, or conditions associated with increased risk for HBV infection:

  • Persons incarcerated or formerly incarcerated in a jail, prison, or other detention setting
  • Persons with a history of sexually transmitted infections or multiple sex partners
  • Persons with a history of hepatitis C virus infection

Yes. An overall result interpretation comment will be included on the laboratory result report. This interpretative comment is the most common one associated with the patient’s specific combination of HBV test results from the panel.

Other, less frequently encountered interpretations may be considered by the clinician for any specific combination of hepatitis B screen results, based on the patient’s clinical scenario and epidemiologic risk factors. As with all laboratory test results and interpretations, clinical information needs to be considered (Table). 

In 2023, the CDC estimated 580,000 to 2.4 million people were living with HBV infection in the United States. The CDC estimated that 68% of people with chronic hepatitis B infection are unaware of their infection4 and many remained asymptomatic until they have advanced disease (cirrhosis or end-stage liver disease).5,6

Persons born in regions with a prevalence of HBV infection of 2% or greater, such as countries in Africa and Asia, the Pacific Islands, and parts of South America, often become infected at birth and account for up to 95% of newly reported chronic infections in the United States.7 For 2018, the weighted prevalence of chronic hepatitis B infection among foreign-born individuals was estimated at 3%; approximately 59% of individuals with chronic hepatitis B emigrated from Asia, 19% from the Americas, and 15% from Africa.8

According to the CDC, a total of 3,192 newly diagnosed cases of acute HBV infection were reported in 2019.7 The overall incidence was 1.0 case per 100,000 people. After adjustment for under-ascertainment and under-reporting, an estimated 20,700 acute hepatitis B cases occurred in 2019.3

Acute HBV infections do not always cause symptoms, and the likelihood of signs and symptoms varies with a patient’s age and immune status. Acute HBV infections tend to not cause symptoms in immunosuppressed adults and in children <5 years old, though they are associated with signs and symptoms in up to half (25%-50%) of children ages 1 to 5 years.9 Signs and symptoms of acute HBV infection can include the following9:

  • Fever
  • Fatigue
  • Loss of appetite
  • Nausea
  • Vomiting
  • Abdominal pain
  • Dark urine
  • Clay-colored bowel movements
  • Joint pain
  • Jaundice

The risk for chronic infection varies according to the patient’s age at virus acquisition and is greatest among young children. Approximately 90% of infants infected by vertical transmission from their mothers and approximately 33% of children infected between 1 to 5 years of age will develop chronic hepatitis B. By contrast, 98% or more of individuals who acquire acute hepatitis B later in childhood (at >6 years)9 and approximately 95% of those who acquire it as adults6 will recover completely and not develop chronic infection.9

But some adults do develop chronic HBV and are at increased likelihood of developing liver sclerosis and liver cancer and dying prematurely.10 Chronic HBV infection disproportionately affects people born outside the United States; non-US–born people account for 14% of the general population, but account for 69% of the US population living with chronic HBV infection.11

HBV reactivation is the abrupt reappearance or rise in HBV DNA in a person with previously inactive chronic or resolved hepatitis B. It is often accompanied by a flare in disease activity, demonstrated by an elevation of liver enzymes, with or without symptoms. HBV reactivation can be severe and result in death.12

According to the Centers for Disease Control and Prevention,3 individuals who test positive for both hepatitis B core antibody (HBcAb) and hepatitis B surface antigen (HBsAg) are at substantially higher risk of reactivation than are those who are positive for both HBcAb and HBsAb.

Others at risk include people who:

  • Are undergoing cancer chemotherapy
  • Are taking immunosuppressive therapy, including
    • Rituximab and other drugs that target B lymphocytes (black box warning)
    • High-dose steroids
    • Anti-tumor necrosis factor (TNF) agents, eg, adalimumab (Humira®), etanercept (Enbrel®), and infliximab (Remicade®)
  • Have discontinued therapy for HIV with antiretroviral drugs that also have activity against HBV
  • Are undergoing solid-organ or bone-marrow transplantation
  • Are being treated for HCV coinfection

References

  1. Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018;67(4):1560-1599. doi:10.1002/hep.29800
  2. Conners EE, Panagiotakopoulos L, Hofmeister MG, et al. Screening and testing for hepatitis B virus infection: CDC recommendations—United States, 2023. MMWR Recommendations and Reports. 2023;72(1):1. doi:10.15585/mmwr.rr7201a1
  3. Roberts H, Ly KN, Yin S, et al. Prevalence of hepatitis B virus (HBV) infection, vaccine-induced immunity, and susceptibility among at-risk populations: U.S. households, 2013–2018. Hepatology 2021;74:2353–65. doi 10.1002/hep.3199
  4. Abara  WE, Qaseem  A, Schillie  High Value Care Task Force of the American College of Physicians and the Centers for Disease Control and Prevention. Hepatitis B vaccination, screening, and linkage to care: best practice advice from the American College of Physicians and the Centers for Disease Control and Prevention.   Ann Intern Med. 2017;167(11):794-804. doi:10.7326/M17-1106
  5. McMahon  BJ. The natural history of chronic hepatitis B virus infection. Hepatology. 2009;49(5)(suppl):S45-S55.doi:10.1002/hep.22898
  6. US Preventive Services Task Force. Screening for Hepatitis B Virus Infection in Adolescents and Adults: US Preventive Services Task Force Recommendation Statement. JAMA. 2020;324(23):2415–2422. doi:10.1001/jama.2020.22980
  7. Viral hepatitis surveillance report-United States, 2019. Centers for Disease Control and Prevention. Published May 2021. Accessed November 8, 2023. https://www.cdc.gov/hepatitis/statistics/2019surveillance/pdfs/2019HepSurveillanceRpt.pdf
  8. Lim JK, Nguyen MH, Kim WR, et al. Prevalence of chronic hepatitis B virus infection in the United States. Am J Gastroenterol. 2020;115(9):1429-1438. doi:10.14309/ajg.0000000000000651
  9. Fattovich G, Bortolotti F, Donato F. Natural history of chronic hepatitis B: special emphasis on disease progression and prognostic factors. J Hepatol. 2008;48(2):335–352. doi:10.1016/j.jhep.2007.11.011
  10. Hepatitis B questions and answers for the public. Centers for Disease Control and Prevention. Reviewed July 28, 2020. Accessed November 8, 2023. https://www.cdc.gov/hepatitis/hbv/bfaq.htm#bFAQe02
  11. Wong RJ, Brosgart CL, Welch S, et al. An updated assessment of chronic hepatitis B prevalence among foreign-born persons living in the United States. Hepatology 2021;74:607–626. doi 10.1002/hep.31782
  12. Bixler D, Zhong Y, Ly KN, et al.; CHeCS Investigators. Mortality among patients with chronic hepatitis B infection: the Chronic Hepatitis Cohort Study (CHeCS). Clin Infect Dis 2019;68:956–963. doi 10.1093/cid/ciy598

 

This FAQ is provided for informational purposes only and is not intended as medical advice. Test selection and interpretation, diagnosis, and patient management decisions should be based on the physician’s education, clinical expertise, and assessment of the patient.

 

Document FAQS.214 Version: 1

Version 1: Effective 03/28/2024 to present

Version 0: Effective 11/01/2021 to 03/28/2024

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