Test Catalog

Test Id : HBAG

Hepatitis B Surface Antigen, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

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).

Highlights

This test should be used to test symptomatic individuals who may or may not have risk factors for hepatitis B virus infection.

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Chemiluminescence Immunoassay (CIA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

HBs Antigen, S

Aliases
Lists additional common names for a test, as an aid in searching

Hepatitis Bs Ag

HBsAg (Hepatitis Bs Antigen)

HBV surface antigen

HBV s antigen

Hepatitis B surface antigen

Hepatitis Bs antigen

HBAG

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Specimen Type
Describes the specimen type validated for testing

Serum SST

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 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
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.6 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 28 days
Refrigerated 7 days
Ambient 24 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

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).

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

See Viral Hepatitis Serologic Profiles in Special Instructions.

Interpretation
Provides information to assist in interpretation of the test results

A reactive screen result (signal-to-cutoff ratio [S/Co]: > or =1.00 but < or =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 in Special Instructions:

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

-HBV Infection-Monitoring Before and After Liver Transplantation

-Viral Hepatitis Serologic Profiles

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Positive screen results (ie, signal-to-cutoff ratio >100.0) without need for confirmation testing should be interpreted in conjunction with test results of other hepatitis B virus (HBV) serologic markers (eg, hepatitis B surface antibody [anti-HBs], hepatitis B core antibody [anti-HBc] total, and anti-HBc IgM).

 

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:

-Grossly icteric (total bilirubin level of >20 mg/dL)

-Grossly lipemic (triolein level of >3000 mg/dL)

-Grossly hemolyzed (hemoglobin level of >500 mg/dL)

-Containing particulate matter

-Cadaveric specimens

Clinical Reference
Recommendations for in-depth reading of a clinical nature

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

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

Specimens are first tested by the VITROS hepatitis B surface antigen (HBsAg) assay. With modification to the assay manufacturer's instructions for use, specimens yielding signal-to-cutoff (S/Co) of 1.00 or greater but 100.0 or less will be confirmed by the VITROS HBsAg confirmatory assay. Specimens that are strongly positive (ie, S/Co >100.0) do not require this confirmation.

 

Chemiluminescence Immunoassay:

This immunometric technique involves the simultaneous reaction of HBsAg in the sample with mouse monoclonal anti-hepatitis B surface (anti-HBs) antibody coated onto the wells and a horseradish peroxidase (HRP)-labeled mouse monoclonal anti-HBs antibody in the conjugate. Unbound conjugate is removed by washing. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The light signals are read by the system. The amount of HRP conjugate bound is indicative of the level of HBsAg present in the sample.(Package insert: VITROS HBsAg assay, no. GEM1201, version 13.1. Ortho-Clinical Diagnostics, Inc; 09/06/2019)

 

Confirmation:

The VITROS HBsAg Confirmatory kit uses the principle of specific antibody neutralization to confirm the presence of HBsAg. The sample is tested twice: the first aliquot is incubated with a neutralizing reagent containing high titer anti-HBs (the confirmatory antibody); the second aliquot is incubated with a non-neutralizing control reagent (the sample diluent). The confirmatory antibody binds to HBsAg in the sample inhibiting its reaction in the VITROS HBsAg assay. This leads to a reduced result compared to that for the non-neutralized control sample.(Package insert: VITROS HBsAg Confirmation assay, no. GEM4201, version 13.1. Ortho-Clinical Diagnostics Inc; 09/06/2019)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87340

87341 (if appropriate)

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
HBAG HBs Antigen, S 5196-1
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
H_BAG HBs Antigen, S 5196-1

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Create a PDF

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports