Hepatitis B Virus Surface Antigen, Serum

Reporting Name

HBs Antigen, S

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful 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.

Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Ordering 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 Type

Serum SST

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

Reject Due To

Gross hemolysis	Reject
Gross lipemia	Reject
Gross icterus	Reject

Reference Values

Negative

See Viral Hepatitis Serologic Profiles

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

-Viral Hepatitis Serologic Profiles

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

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

Forms

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

Reflex Tests

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

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.