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Test ID: HBGSN Hepatitis B Surface Antigen Screen, Serum


Ordering Guidance


This test should not be used to test symptomatic individuals (ie, diagnostic purposes) who may or may not have risk factors for hepatitis B virus (HBV) infection. For testing such patients, order HBAG / Hepatitis B Surface Antigen, Serum.

 

This test should not be used to test or screen for chronic hepatitis B in pregnant individuals. 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 (HBV) 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. Aliquot serum into plastic vial.


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
HBGSC HBs Antigen Screen Confirmation, S No No

Testing Algorithm

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

 

The following algorithms are available:

-HBV Infection-Monitoring Before and After Liver Transplantation

-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

Method Name

Chemiluminescence Immunoassay

Reporting Name

HBs Antigen 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) 28 days
  Refrigerated  7 days
  Ambient  24 hours

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

 

The following algorithms are available:

-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

-HBV Infection-Monitoring Before and After Liver Transplantation

Reference Values

Negative

See Viral Hepatitis Serologic Profiles in Special Instructions.

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, HBs 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:

-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

-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. Antivir 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. 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 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 Aug 22;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: WHO guidelines on hepatitis B and C testing. World Health Organization; 2017. Accessed July 8, 2021. Available at www.who.int/publications/i/item/9789241549981

8. Centers for Disease Control and Prevention: Testing and public health management of persons with chronic hepatitis B virus infection. CDC; Updated October 8, 2019. Accessed April 8, 2020. Available at www.cdc.gov/hepatitis/hbv/testingchronic.htm

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

87340

G0499 (if appropriate)

87341 (if appropriate)

LOINC Code Information

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

 

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

Forms

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

Mayo Clinic Laboratories | Microbiology and Infectious Disease Catalog Additional Information:

mml-hepatitis