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HelpTest ID: HBAG Hepatitis B Surface Antigen, Serum
Reporting Name
HBs Antigen, SUseful 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).
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-Monitoring Before and After Liver Transplantation
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
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:
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
-HBV Infection-Monitoring Before and After Liver Transplantation
Report Available
Same day/1 to 3 daysDay(s) Performed
Monday through Saturday
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
Method Name
Chemiluminescence Immunoassay (CIA)
Specimen Type
Serum SSTOrdering Guidance
This test should not be used to test or screen for chronic hepatitis B in pregnant women. For testing such patients, order HBAGP / Hepatitis B Surface Antigen Prenatal, Serum.
This test should not be used to screen or test asymptomatic, nonpregnant individuals with or without risk factors for hepatitis B virus (HBV) infection. For testing such patients, order HBGSN / Hepatitis B Surface Antigen Screen, 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. Aliquot serum into plastic vial.
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 |
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
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 |
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:
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
-HBV Infection-Monitoring Before and After Liver Transplantation
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HBGNT | HBs Antigen Confirmation, S | No | No |
Special Instructions
Forms
If not ordering electronically, complete, print, and send Gastroenterology and Hepatology Client Test Request (T728) with the specimen.
mml-hepatitis