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Test ID: HBBSN Hepatitis B Virus Surface Antibody Screen, Qualitative/Quantitative, Serum


Ordering Guidance


If patient is being monitored for hepatitis B immune globulin (HBIG) therapy after organ transplantation, order HBABT / Hepatitis B Virus Surface Antibody Monitor, Post-Transplant, Serum.

 

This test should not be used for prenatal screening of pregnant individuals with or without risk factors for hepatitis B virus (HBV) infection. For testing such, order HBABP / Hepatitis B Virus Surface Antibody Prenatal, Qualitative/Quantitative, Serum.

 

This test should not be used for diagnostic testing of symptomatic individuals to evaluate post-vaccination immunity status or post-acute infection status of HBV. For testing such patients, order HBAB / Hepatitis B Virus Surface Antibody, Qualitative/Quantitative, Serum.



Necessary Information


Date of collection is required.



Specimen Required


Patient Preparation: For 24 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Serum gel (red-top tubes are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 0.7 mL

Collection Instructions:

1. Centrifuge blood collection tube per manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot serum into plastic vial.


Useful For

Identifying previous exposure to hepatitis B virus

Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Reporting Name

HBs Antibody Scrn, S

Specimen Type

Serum SST

Specimen Minimum Volume

0.6 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 90 days
  Refrigerated  6 days
  Ambient  7 hours

Clinical Information

Hepatitis B virus (HBV) is a DNA virus that is endemic throughout the world. The infection is spread primarily through blood transfusion or percutaneous contact with infected blood products, such as sharing needles among injection drug users. The virus is 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 and in 5% to 10% of infected individuals 5 years or older. Some 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 8 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.

Reference Values

Hepatitis B Surface Antibody

Unvaccinated: Negative

Vaccinated: Positive

 

Hepatitis B Surface Antibody, Quantitative

Unvaccinated: <8.5 mIU/mL

Vaccinated: ≥11.5 mIU/mL

 

See Viral Hepatitis Serologic Profiles

Clinical Reference

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. LeFevre 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;161(1):58-66. doi:10.7326/M14-1018

3. Jackson K, Locarnini S, Gish R. Diagnostics of hepatitis B virus: Standard of care and investigational. Clin Liver Dis. 2018;12(1):5-11. doi:10.1002/cld.729

4. Coffin CS, Zhou K, Terrault NA. New and old biomarkers for diagnosis and management of chronic hepatitis B virus infection. Gastroenterology. 2019;156(2):355-368. doi:10.1053/j.gastro.2018.11.037

5. WHO guidelines on hepatitis B and C testing. Geneva: World Health Organization; February 2017. Accessed December 19, 2023. Available at www.who.int/publications/i/item/9789241549981

6. Conners EE, Panagiotakopoulos L, Hofmeister MG, et al. Screening and Testing for Hepatitis B Virus Infection: CDC Recommendations - United States, 2023. MMWR Recomm Rep. 2023;72(1):1-25. doi:10.15585/mmwr.rr7201a1

Day(s) Performed

Monday through Saturday

Report Available

Same day/1 to 3 days

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

86706

G0499 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HBBSN HBs Antibody Scrn, S 5193-8

 

Result ID Test Result Name Result LOINC Value
HBASN HBs Antibody Scrn, S 10900-9
HBSQN HBs Antibody, Quantitative, S 5193-8

Forms

If not ordering electronically, complete, print, and send 1 of the following:

-Gastroenterology and Hepatology Test Request (T728)

-Infectious Disease Serology Test Request (T916)

Interpretation

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 HBV. A positive total hepatitis B core antibody 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 11.5 mIU/mL or greater, indicate adequate immunity to HBV from past hepatitis B or HBV vaccination. However, per current Centers for Disease Control and Prevention guidance,(1) individuals with anti-HBs levels greater than 10 mIU/mL after completing an HBV vaccination series are considered protected from hepatitis B infection.

 

Negative results, defined as anti-HBs levels of less than 8.5 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 vaccine nonresponders.

 

Indeterminate results, defined as anti-HBs levels in the range from 8.5 to less than 11.5 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 2 months to determine definitive anti-HBs status.

 

For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management.

Mayo Clinic Laboratories | Gastroenterology Catalog Additional Information:

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