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HelpMayo Test ID HBGCD Hepatitis B Surface Antigen for Cadaveric or Hemolyzed Specimens, Serum
Additional Testing Requirements
Testing for acute hepatitis B virus (HBV) infection should also include HBIM / Hepatitis B Core Antibody, IgM, Serum as during the acute HBV infection "window period," HB surface (HBs) antigen and HBs antibody may not be detected.
Necessary Information
Date of collection is required.
Specimen Required
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 2 mL
Collection instructions:
1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot serum into plastic vial.
Useful For
Testing cadaveric and hemolyzed blood specimens for hepatitis B surface antigen (HBsAg); US Food and Drug Administration-licensed for use with hemolyzed specimens
Diagnosis of acute, recent (<6-month duration), or chronic hepatitis B infection; determination of chronic hepatitis B carrier status
This test is not useful during the "window period" of acute hepatitis B virus (HBV) infection, (ie, after disappearance of HBsAg and prior to appearance of anti-HBs antibody).
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| BNTCD | HBsAg Confirm Cadav/Hemol, S | No | No |
Testing Algorithm
All reactive results are confirmed by a neutralization procedure at an additional charge.
Method Name
Enzyme Immunoassay (EIA)
Reporting Name
HBsAg Cadaver/Hemolyzed, SSpecimen Type
SerumSpecimen Minimum Volume
1.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Frozen (preferred) | 30 days | |
| Ambient | 7 days | ||
| Refrigerated | 7 days |
Reject Due To
| Gross hemolysis | OK |
| Gross lipemia | Reject |
| Gross icterus | Reject |
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 users). The virus is 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; 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 HBV infection. In acute infection, HBsAg usually disappears in 1 to 2 months after the onset of symptoms. Persistence of HBsAg for greater than 6 months indicates development of either a chronic carrier or chronic HBV infection.
Reference Values
Negative
Interpretation
A positive result (reactive screening and confirmed positive by neutralization test) is indicative of acute or chronic hepatitis B virus (HBV) infection or chronic HBV carrier state.
A positive confirmatory test result is considered the definitive test result for hepatitis B surface antigen (HBsAg). Specimens that are reactive by the screening test but negative (not confirmed) by the confirmatory test are likely to contain cross-reactive antibodies from other infectious or immunologic disorders. These unconfirmed HBsAg screening test results should be interpreted in conjunction with test results of other HBV serological markers (eg, anti-hepatitis B surface antibody, anti-hepatitis B core total antibody).
The presence of HBsAg is frequently associated with HBV infectivity, especially when accompanied by the presence of HBeAg or HBV DNA.
Cautions
Positive hepatitis B surface antigen (HBsAg) test results should be reported by the health care provider to the State Department of Health, as required by law in some states.
Individuals, especially neonates and children, who recently received hepatitis B vaccination may have transient-positive HBsAg test results because of the large dose of HBsAg used in the vaccine relative to the individual's body mass.
Performance characteristics have not been established for the following specimen characteristics:
-Icteric cadavers
-Lipemic cadavers
-Containing particulate matter
Clinical Reference
1. Servoss JC, Friedman LS: Serologic and molecular diagnosis of hepatitis B virus. Clin Liver Dis. 2004 May;8(2):267-281
2. Badur S, Akgun A: Diagnosis of hepatitis B infections and monitoring of treatment. J Clin Virol. 2001 Jun;21(3):229-237
3. Bonino F, Piratvisuth T, Brunetto MR, Liaw YF: Diagnostic markers of chronic hepatitis B infection and disease. Antivir Ther. 2010;15 Suppl 3:35-44
4. Terrault NA, Bzowej NH, Chang KM, et al: AASLD guidelines for treatment of chronic hepatitis B. Hepatology. 2016 Jan;63(1):261-283
Method Description
Specimens are first screened by the Genetic Systems hepatitis B surface antigen (HBsAg) 3.0 EIA. All reactive results are confirmed by the Genetic Systems HBsAg Confirmatory Assay 3.0 (HBsAg Neutralization) at an additional charge.
HBsAg:
The Bio-Rad GS HBsAg EIA 3.0 is a qualitative third-generation enzyme immunoassay which uses mouse monoclonal antibodies to detect anti-HBsAg in human serum or cadaveric serum specimens. Wells of a microwell strip plate are coated with mouse monoclonal antibody to HBsAg (anti-HBs). Patient serum and appropriate controls are added to the wells and incubated with bound antibody. If HBsAg is present, it will bind to the antibody and not be removed by washing. The strips are washed to remove any unbound material. Washing is followed by the addition of conjugate solution (peroxidase-conjugated mouse monoclonal antibodies directed against HBsAg). The conjugate solution will bind to the antibody-HBsAg complex, if present. Unbound conjugate is removed by a wash step. Next, working 3,3',5,5'-tetramethylbenzidine (TMB) solution is added to the plate and allowed to incubate. A blue or blue-green color develops in proportion to the amount of HBsAg present in the sample. The enzyme reaction is stopped by the addition of acid, which changes the blue-green color to yellow. The absorbance values of controls and specimens are determined using a spectrophotometer with wavelength set at 450 nm.(Package insert: Genetic Systems HBsAg 3.0 EIA. Bio-Rad Laboratories; 02/2019)
HBsAg Confirmation:
The repeatedly reactive specimen is incubated with HBsAg confirmatory reagent (human antibody to HBsAg). If HBsAg is present in the specimen, it will be neutralized by the HBsAg confirmatory reagent. The treated specimen is re-assayed using the Genetic Systems HBsAg 3.0 EIA assay. The neutralized HBsAg is prevented from binding to the HBsAg antibody-coated microwells, which results in a reduction of signal. A non-neutralized control of the specimen (treated with HBsAg-negative control [human] in place of the HBsAg confirmatory reagent) is tested in parallel to the neutralized specimen for comparison of signal. Genetic Systems HBsAg EIA 3.0 repeatedly reactive specimens are confirmed as positive by the Genetic Systems HBsAg Confirmatory Assay 3.0 if the reduction in signal of the neutralized specimen is greater than or equal to 50% of the corresponding non-neutralized specimen, and the non-neutralized specimen signal is greater than or equal to the assay cutoff.(Package insert: Genetic Systems HBsAg Confirmatory Assay 3.0. Bio-Rad Laboratories; 01/2009)
Day(s) Performed
Monday, Thursday
Report Available
1 to 7 daysSpecimen Retention Time
14 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
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 |
|---|---|---|
| HBGCD | HBsAg Cadaver/Hemolyzed, S | In Process |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 83626 | HBsAg Cadaver/Hemolyzed, S | 5196-1 |