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Test ID: HBAG Hepatitis B Surface Antigen, Serum

Reporting Name

HBs Antigen, S

Useful For

Diagnosis of acute, recent, or chronic hepatitis B infection

 

Determination of chronic hepatitis B infection status

 

This test is not offered as a screening or confirmatory test for blood donor specimens.

 

This test, by itself , is not useful during the "window period" of acute hepatitis B virus (HBV) infection (ie, after disappearance of hepatitis B surface antigen and prior to appearance of hepatitis B surface antibody ). Testing for acute HBV infection should also include hepatitis B core IgM antibody (anti-HBc IgM).

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HBGNT HBs Antigen Confirmation, S No No

Testing Algorithm

If hepatitis B surface antigen (HBsAg) screen is reactive with signal-to-cutoff (S/CO) ratio in the range of 1.00 to 100.0 then HBsAg confirmation will be performed at an additional charge.

 

See the following in Special Instructions:

-HBV Infection-Diagnostic Approach and Management Algorithm

-HBV Infection-Monitoring Before and After Liver Transplantation

Specimen Type

Serum SST


Advisory Information


This test is not intended for stand-alone prenatal screening for chronic hepatitis B in pregnant women.

For testing such patients, order HBAGP / Hepatitis B Surface Antigen Prenatal, Serum.

 

This test is not intended for testing cadaver or grossly hemolyzed specimens. For testing such patients, order HBGCD / Hepatitis B Surface Antigen for Cadaveric or Hemolyzed Specimens, Serum, which is FDA-approved for testing on these sources.



Additional Testing Requirements


Testing for acute hepatitis B virus infection should also include HBIM / Hepatitis B Core Antibody, IgM, Serum, as during the acute HBV infection "window period", Hepatitis B surface (HBs) antigen and HBs antibody may not be detected.



Necessary Information


1. Date of collection is required.

2. Indicate if specimens are from autopsy/cadaver or hemolyzed sources so that the proper FDA-licensed assay can be performed.



Specimen Required


Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 2 mL

Collection Instructions: 

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

2. Transfer serum into aliquot tube.


Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 28 days
  Refrigerated  7 days
  Ambient  24 hours

Reference Values

Negative

See Viral Hepatitis Serologic Profiles in Special Instructions.

Day(s) and Time(s) Performed

Monday through Saturday; Varies 

Test Classification

This test has been cleared, approved or is exempt by the U.S. 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

87340

87341 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HBAG HBs Antigen, S 5196-1

 

Result ID Test Result Name Result LOINC Value
H_BAG HBs Antigen, S 5196-1

Clinical Information

Hepatitis B virus (HBV) is endemic throughout the world. The infection is spread primarily through percutaneous contact with infected blood products (eg, blood transfusion, sharing of needles by intravenous drug addicts). The virus is also found in various human body fluids, and it is known to be spread through oral and genital contacts. HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions, but it is not commonly transmitted transplacentally.

 

Hepatitis B surface antigen (HBsAg) is the first serologic marker appearing in the serum at 6 to 16 weeks following exposure to HBV. In acute infection, HBsAg usually disappears in 1 to 2 months after the onset of symptoms. Persistence of HBsAg for more than 6 months in duration indicates development of either a chronic carrier state or chronic HBV infection.

 

See the following in Special Instructions:

-HBV Infection-Diagnostic Approach and Management Algorithm

-HBV Infection-Monitoring Before and After Liver Transplantation

Interpretation

A reactive screen result (signal-to-cutoff ratio [S/Co]: ≥1.00, but ≤100.0) confirmed as positive by hepatitis B surface antigen (HBsAg) confirmatory test (see Method Description) or a positive screen result (S/Co >100.0) is indicative of acute or chronic hepatitis B virus (HBV) infection, or chronic HBV carrier state.

 

Specimens with initially reactive screen results, but negative (not confirmed) by HBsAg confirmatory test results, are likely to contain cross-reactive antibodies from other infectious or immunologic disorders. These unconfirmed HBsAg-reactive screening test results should be interpreted in conjunction with test results of other HBV serologic markers (eg, hepatitis B surface antibody; hepatitis B core antibody, total and IgM). Repeat testing is recommended at a later date if clinically indicated.

 

Confirmed presence of HBsAg is frequently associated with HBV replication and infectivity, especially when accompanied by presence of hepatitis B e antigen and/or detectable HBV DNA.

 

See the following in Special Instructions:

-HBV Infection-Diagnostic Approach and Management Algorithm

-HBV Infection-Monitoring Before and After Liver Transplantation

-Viral Hepatitis Serologic Profiles

Clinical Reference

1. Bonino F, Piratvisuth T, Brunetto MR, Liaw YF: Diagnostic markers of chronic hepatitis B infection and disease. Antiviral Ther. 2010;15(3):35-44

2. Servoss JC, Friedman LS: Serologic and molecular diagnosis of hepatitis B virus. Clin Liver Dis. 2004 May;8(2):267-281

3. Badur S, Akgun A: Diagnosis of hepatitis B infections and monitoring of treatment. J Clin Virol. 2001 Jun;21(3):229-237

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

Analytic Time

1 day

Method Name

Chemiluminescence Immunoassay

Forms

If not ordering electronically, complete, print, and send a Gastroenterology and Hepatology Client Test Request (T728) with the specimen.

Mayo Clinic Laboratories | Gastroenterology Catalog Additional Information:

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