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HBV 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.1,2 The components of this panel include

  • Hepatitis B Surface Antigen with Reflex Confirmation (test code 498[X])
  • Hepatitis B Core Antibody, Total, with Reflex to IgM (test code 37676[X])
  • Hepatitis B Surface Antibody Immunity, Quantitative (8475[X])

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 several organizations.1,2

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.  

Applying the findings of the 2016 US National Health and Nutrition Examination Survey (NHANES) to the US Census Bureau population in 2021 results in a conservative estimate of an overall hepatitis B prevalence of 1.16 million persons.3

The weighted average chronic hepatitis B infection prevalence in the US in 2018 for foreign-born individuals was estimated at 3%. Approximately 59% of those individuals emigrated from Asia, 19% from the Americas, and 15% from Africa.4

It is estimated that only 25% of individuals with hepatitis B have been diagnosed.4 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.

According to the US Centers for Disease Control and Prevention (CDC), a total of 3,192 newly diagnosed cases of acute HBV infection were reported in 2019. The overall incidence was 1.0 case per 100,000 population. After adjustment for under-ascertainment and under-reporting, an estimated 20,700 acute hepatitis B cases occurred in 2019.4


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 be asymptomatic in children <5 years old, and in immunosuppressed adults, but are associated with signs and symptoms in up to half (25%-50%) of children ages 1 to 5 years.5 Signs and symptoms of acute HBV infection can include the following5:

  • 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, almost all individuals who acquire acute hepatitis B later in childhood (at >6 years)5 and approximately 95% of those who acquire it as adults6 will recover completely and not develop chronic infection.5  

An estimated 862,000 persons in the US are living with chronic infection with HBV.7

Most people with chronic HBV infection are asymptomatic and have no evidence of liver disease. However, some people may develop elevations of serum AST/ALT, cirrhosis, or hepatocellular carcinoma.8

In 2018, a total of 1,649 US death certificates had HBV recorded as an underlying or contributing cause of death.9 However, this is a conservative estimate.

The following individuals should be screened for HBV infection because of increased risk of HBV infection8:

  • People born in countries with 2% or higher HBV prevalence (highest prevalence is in Africa at 6.1% and in the Western Pacific region at 6.3%); please refer to the CDC for further information10  
  • People born in the United States not vaccinated as infants whose parents were born in regions with high rates of HBV infection (Hepatitis B Surface Antigen [HBsAg] prevalence of > 8%)
  • Men who have sex with men 
  • People who inject drugs
  • Persons living with HIV
  • Household and sexual contacts of persons living with HBV with hepatitis B
  • People requiring immunosuppressive therapy
  • People with end-stage renal disease (including hemodialysis patients)
  • Blood and tissue donors
  • People with elevated alanine aminotransferase levels (>19 IU/L for women and >30 IU/L for men)
  • Pregnant women (only HBsAg is recommended)
  • Infants born to mothers with hepatitis B (only HBsAg and anti-HBsAb are recommended)
  • Patients at risk for HBV reactivation11

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, resulting in death.12

According to the CDC,8 individuals who test positive for both anti-HB core and HBsAg are at substantially higher risk of reactivation than are those who are positive for both anti-HB core and anti-HB surface.

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-TNF agents
  • 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.     Weinbaum CM, William I, Mast EE, et al. Recommendations for identification and public health management of persons with chronic hepatitis B virus infection. MMWR Recomm Rep. 2008;57(RR-8):1-20.

3.     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

4.     Viral hepatitis surveillance report-United States, 2019. Centers for Disease Control and Prevention. Published May 2021. Accessed September 16, 2021. https://www.cdc.gov/hepatitis/statistics/2019surveillance/pdfs/2019HepSurveillanceRpt.pdf

5.     Hepatitis B questions and answers for the public. Centers for Disease Control and Prevention. Reviewed July 28, 2020. Accessed September 16, 2021. https://www.cdc.gov/hepatitis/hbv/bfaq.htm#bFAQe02

6.     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

7.     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

8.     Hepatitis B questions and answers for health professionals. Centers for Disease Control and Prevention. Reviewed July 28, 2020. Accessed September 16, 2021. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm#treatment

9.     Hoofnagle JH, Di Bisceglie AM. Serologic diagnosis of acute and chronic viral hepatitis. Semin Liver Dis.1991;11(2):73-83. doi:10.1055/s-2008-1040426

10.  Travel-related infectious diseases. Centers for Disease Control and Prevention. Reviewed July 1, 2019. Accessed September 16, 2021. https://wwwnc.cdc.gov/travel/yellowbook/2020/travel-related-infectious-diseases/hepatitis-b#5182

11.  Reddy KR, Beavers KL, Hammond SP, et al. American Gastroenterological Association Institute guideline on the prevention and treatment of hepatitis B virus reactivation during immunosuppressive drug therapy. Gastroenterology. 2015;148(1): 215-219. doi:10.1053/j.gastro.2014.10.039

12.  Hsu C, Tsou HH, Lin SJ, et al. Chemotherapy-induced hepatitis B reactivation in lymphoma patients with resolved HBV infection: a prospective study. Hepatology. 2014;59(6):2092-2100. doi:10.1002/hep.26718

 

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.

 

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Effective 11/01/2021 to present

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