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Test ID: HBGSN Hepatitis B Virus 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 infection. For testing such patients, order HBAG / Hepatitis B Virus 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 Virus 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 US Food and Drug Administration approved for testing on these sources.



Additional Testing Requirements


Testing for acute hepatitis B virus infection (HBV) should also include HBIM / Hepatitis B Virus IgM Core Antibody, Serum, as during the acute HBV infection "window period," hepatitis B virus 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 US Food and Drug Administration licensed assay can be performed.



Specimen Required


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: 0.9 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 a plastic vial.


Useful For

Diagnosis of acute, recent, or chronic hepatitis B

 

Determination of chronic hepatitis B status

 

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

 

This test is not useful for diagnosis of hepatitis B during the “window period" of acute hepatitis B (ie, after disappearance of hepatitis B surface antigen and prior to appearance of hepatitis B surface antibody).

Reflex Tests

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

Testing Algorithm

If the hepatitis B virus surface antigen (HBsAg) result is reactive with a cutoff index value greater than 1.00, then HBsAg confirmation testing will be performed at an additional charge.

 

The following algorithms are available:

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

-HBV Infection-Monitoring Before and After Liver Transplantation

Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Reporting Name

HBs Antigen Scrn, S

Specimen Type

Serum SST

Specimen Minimum Volume

0.7 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 90 days
  Refrigerated  6 days
  Ambient  72 hours

Clinical Information

Hepatitis B virus (HBV) is a DNA virus that is endemic throughout the world. The infection is spread primarily through percutaneous contact with infected blood products (eg, blood transfusion, sharing of needles among injection drug users). 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 virus surface antigen (HBsAg) is the first serologic marker appearing in the serum at 6 to 8 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.

Reference Values

Negative

 

See Viral Hepatitis Serologic Profiles

Interpretation

A reactive screen result (cutoff index value >1.00) confirmed as positive by hepatitis B virus surface antigen (HBsAg) confirmatory test is indicative of acute or chronic hepatitis B or chronic hepatitis B virus (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 [HBc] total antibody, and HBc IgM antibody). If clinically indicated, repeat testing at a later date is recommended.

 

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

 

See the following:

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

-HBV Infection-Monitoring Before and After Liver Transplantation

-Viral Hepatitis Serologic Profiles

Clinical Reference

1. 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

2. Jackson K, Locarnini S, Gish R. Diagnostics of Hepatitis B Virus: Standard of Care and Investigational. Clin Liver Dis (Hoboken). 2018;12(1):5-11. doi:10.1002/cld.729

3. 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.e3. doi:10.1053/j.gastro.2018.11.037

4. WHO guidelines on hepatitis B and C testing. Geneva: World Health Organization; February 2017. Accessed December 21, 2023. Available at www.who.int/publications/i/item/9789241549981

5. Centers for Disease Control and Prevention. Testing and public health management of persons with chronic hepatitis B virus infection. CDC; Updated March 28, 2022. Accessed December 21, 2023. Available at www.cdc.gov/hepatitis/hbv/testingchronic.htm

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

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 Test Request (T728) with the specimen.

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

mml-hepatitis