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HelpTest ID: HBAG Hepatitis B Virus Surface Antigen, Serum
Reporting Name
HBs Antigen, SUseful For
Diagnosis of acute, recent, or chronic hepatitis B
Determination of chronic hepatitis B status
This test should not be used as a screening or confirmatory test for blood donor specimens.
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 contact. HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions, but it is not commonly transmitted transplacentally.
HBV 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.
Interpretation
A reactive screen result (cutoff index value >1.00) confirmed as positive by hepatitis B 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.
For more information see:
-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. 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. 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. 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 23, 2024. 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 6, 2024. Accessed December 23, 2024. Available at www.cdc.gov/hepatitis-b/hcp/diagnosis-testing/
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
Method Name
Electrochemiluminescence Immunoassay (ECLIA)
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 Virus 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 Virus 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 US Food and Drug Administration-approved for testing on these sources.
Additional Testing Requirements
Testing for acute hepatitis B virus infection should also include HBIM / Hepatitis B Virus IgM Core Antibody Serum, as during the acute hepatitis B virus 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-approved 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.
Specimen Minimum Volume
0.7 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum SST | Frozen (preferred) | 90 days |
| Refrigerated | 6 days | |
| Ambient | 72 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 the hepatitis B virus surface antigen (HBsAg) result is reactive with cutoff index value greater than 1.00, then HBsAg confirmation testing will be performed at an additional charge.
For more information see:
-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 Test Request (T728) with the specimen.
mml-hepatitis