Referred Tests
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Test ID: HBAB
Hepatitis B Surface Antibody, Qualitative/Quantitative, Serum
Useful For 
Suggests clinical disorders or settings where the test may be helpful
Identifying previous exposure to hepatitis B virus
Determining adequate immunity from hepatitis B vaccination
Testing Algorithm Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
See HBV Infection-Diagnostic Approach and Management Algorithm in Special Instructions
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Hepatitis B virus (HBV) infection, also known as serum hepatitis, is endemic throughout the world. The infection is spread primarily through blood transfusion or percutaneous contact with infected blood products, such as sharing of needles among injection drug users. The virus is also found in virtually every type of human body fluid and has been known to be spread through oral and genital contact. HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions, but it is not commonly transmitted via the transplacental route.
The incubation period for HBV infection averages 60 to 90 days (range of 45-180 days). Common symptoms include malaise, fever, gastroenteritis, and jaundice (icterus). After acute infection, HBV infection becomes chronic in 30% to 90% of infected children younger than 5 years of age and in 5% to 10% of infected individuals age 5 or older. Some of these chronic carriers are asymptomatic, while others progress to chronic liver disease, including cirrhosis and hepatocellular carcinoma.
Hepatitis B surface antigen (HBsAg) is the first serologic marker, appearing in the serum 6 to 16 weeks following HBV infection. In acute cases, HBsAg usually disappears 1 to 2 months after the onset of symptoms with the appearance of hepatitis B surface antibody (anti-HBs). Anti-HBs also appears as the immune response following hepatitis B vaccination.
See HBV Infection-Diagnostic Approach and Management Algorithm in Special Instructions
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
HEPATITIS B SURFACE ANTIBODY
Unvaccinated: negative
Vaccinated: positive
HEPATITIS B SURFACE ANTIBODY, QUANTITATIVE
Unvaccinated: <5.0 mIU/mL
Vaccinated: > or =12.0 mIU/mL
See Viral Hepatitis Serologic Profiles in Special Instructions.
Interpretation Provides information to assist in interpretation of the test results
A positive result indicates recovery from acute or chronic hepatitis B virus (HBV) infection or acquired immunity from HBV vaccination. This assay does not differentiate between a vaccine-induced immune response and an immune response induced by infection with HBV. A positive total antihepatitis B core (anti-HBc) result would indicate that the hepatitis B surface antibody (anti-HBs) response is due to past HBV infection.
Per assay manufacturer's instructions for use, positive results, defined as anti-HBs levels of 12.0 mIU/mL or greater, indicate adequate immunity to hepatitis B from past hepatitis B or HBV vaccination. However, per current CDC guidance,(1) individuals with anti-HBs levels greater than 10 mIU/mL after completing an HBV vaccination series are considered protected from hepatitis B.
Negative results, defined as anti-HBs levels of less than 5.0 mIU/mL, indicate a lack of recovery from acute or chronic hepatitis B or inadequate immune response to HBV vaccination. The US Advisory Committee on Immunization Practices does not recommend more than 2 HBV vaccine series in nonresponders.
Indeterminate results, defined as anti-HBs levels in the range from 5 to 11.9 mIU/mL, indicate inability to determine if anti-HBs is present at levels consistent with recovery or immunity. Repeat testing is recommended in 1 to 3 months.
See -HBV Infection-Diagnostic Approach and Management Algorithm in Special Instructions.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Individuals who have received blood component therapies (eg, whole blood), plasma, or intravenous immunoglobulin infusion) in the previous 3 to 6 months may have false-positive hepatitis B surface antibody (anti-HBs) results due to passive transfer of anti-HBs present in these products.
Individuals possessing IgM anti-rubella virus may have falsely high results with the VITROS Anti-HBs quantitative test.
Anti-HBs levels from past hepatitis B or hepatitis B virus (HBV) vaccination may fall below detectable levels over time.
A positive anti-HBs result does not exclude infection by another hepatitis virus.
Performance characteristics have not been established for the following specimen characteristics:
-Grossly icteric (total bilirubin level of >20 mg/dL)
-Grossly lipemic (triglyceride level of >3000 mg/dL)
-Grossly hemolyzed (hemoglobin level of >500 mg/dL)
-Containing particulate matter
-Cadaveric specimens
-Body fluids other than serum (eg, saliva, urine, CSF, amniotic, peritoneal, or pleural fluids)
Clinical Reference Recommendations for in-depth reading of a clinical nature
1. Advisory Committee on Immunization Practices; Centers for Disease Control and Prevention: Immunization of health-care personnel: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011 Nov 25;60(RR-7):1-45
2. Badur S, Akgun A: Diagnosis of hepatitis B infections and monitoring of treatment. J Clin Virol. 2001 Jun;21(3):229-237
3. Servoss JC, Friedman LS: Serologic and molecular diagnosis of hepatitis B virus. Clin Liver Dis. 2004 May;8(2):267-281
4. LeFebre ML, U.S. Preventive Services Task Force: Screening for hepatitis B virus infection in nonpregnant adolescents and adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Jul 1;161(1):58-66. doi:10.7326/M14-1018
5. Jackson K, Locarnini S, Gish R: Diagnostics of hepatitis B virus: Standard of care and investigational. Clin Liver Dis. 2018 Jul;12(1):5-11. doi: 10.1002/cld.729
6. Coffin CS, Zhou K, Terrault NA: New and old biomarkers for diagnosis and management of chronic hepatitis B virus infection. Gastroenterology. 2019 Jan;156(2):355-368. doi: 10.1053/j.gastro.2018.11.037
7. WHO Guidelines Development Group: World Health Organization: Guidelines on hepatitis B and C testing.World Health Organization; 2017. Accessed September 29, 2020. Available at www.who.int/hepatitis/publications/guidelines-hepatitis-c-b-testing/en/
8. Centers for Disease Control and Prevention: Testing and public health management of persons with chronic hepatitis B virus infection. Accessed April 8, 2020. Available at www.cdc.gov/hepatitis/hbv/testingchronic.html