Test ID: HBAG
Hepatitis B Surface Antigen, Serum
NY State Approved 
Indicates the status of NY State approval and if the test is orderable for NY State clients.
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
Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HBGNT | HBs Antigen Confirmation, S | No | No |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
If hepatitis B surface antigen (HBsAg) screen is reactive with S/CO ratio in the range of 1.00 to 50.0, then HBsAg confirmation will be performed at an additional charge.
The following algorithms are available in Special Instructions:
-HBV Infection-Diagnostic Approach and Management Algorithm
-HBV Infection-Monitoring Before and After Liver Transplantation
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
Chemiluminesence Immunoassay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Hepatitis B Surface Antigen
Hepatitis Bs Ag
HBsAg
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 2 mL
Collection Instructions: Spin down and remove serum from clot within 24 hours.
Additional Information:
1. Date of draw is required.
2. Indicate if specimens are from autopsy/cadaver or hemolyzed sources so that the proper FDA-licensed assay can be performed.
Forms: If not ordering electronically, submit a General Request Form (Supply T239) with the specimen.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross reject |
| Lipemia | Mild OK; Gross reject |
| Icterus | Mild OK; Gross reject |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum SST | Frozen (preferred) | |
| Refrigerated | 7 days | |
| Ambient | 24 hours | |
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 >6 months in duration indicates development of either a chronic carrier state or chronic HBV infection.
See The Laboratory Approach to the Diagnosis and Monitoring of Hepatitis B Infection in Publications.
See the following in Special Instructions:
-HBV Infection-Diagnostic Approach and Management Algorithm
-HBV Infection-Monitoring Before and After Liver Transplantation
-Viral Hepatitis Serologic Profile
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 =50.0) confirmed as positive by hepatitis B surface antigen (HBsAg) confirmatory test (see Method Description) or a positive screen result (S/CO >50.0) is indicative of acute or chronic hepatitis B virus (HBV) infection, or chronic HBV carrier state.
Specimens with reactive screen results but negative (ie, not confirmed) HBsAg confirmatory test results are likely to contain cross-reactive antibodies from other infectious or immunologic disorders. 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 Be antigen and/or detectable HBV DNA.
See the following in Special Instructions:
-HBV Infection-Diagnostic Approach and Management Algorithm
-HBV Infection-Monitoring Before and After Liver Transplantation
-Viral Hepatitis Serologic Profile
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This test is not offered as a screening or confirmatory test for blood donor specimens.
Not useful during "window period" of acute hepatitis B virus (HBV) infection (ie, after disappearance of hepatitis B surface antigen [(HBsAg] and prior to appearance of hepatitis B surface antibody [anti-HBs]). Testing for acute HBV infection should also include hepatitis B core (HBc) IgM antibody (anti-HBc IgM).
Positive screen results (ie, S/CO >50.0) without need for confirmation testing should be interpreted in conjunction with test results of other HBV serologic markers (eg, anti-HBs, anti-HBc total, and anti-HBc IgM).
Not suitable as stand-alone prenatal screening test of HBsAg status in pregnant women.
Positive 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 >3,000 mg/dL)
-Grossly hemolyzed (hemoglobin level of >500 mg/dL)
-Containing particulate matter
-Cadaveric specimens
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Servoss JC, Friedman LS: Serologic and molecular diagnosis of hepatitis B virus. Clin Liver Dis 2004;8:267-281
2. Badur S, Akgun A: Diagnosis of hepatitis B infections and monitoring of treatment. J Clin Virol 2001;21:229-237
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 S/CO > or =1.00 but < or =50.0 will be confirmed by the VITROS HBsAg Confirmatory assay. Specimens that are strongly positive (ie, S/CO >50.0) do not require this confirmation.
Chemiluminescence Immunoassay:
This immunometric technique involves the simultaneous reaction of HBsAg in the sample with mouse monoclonal 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 VITROS ECi System. The amount of HRP conjugate bound is indicative of the level of HBsAg present in the sample.(Package insert: VITROS HBsAg assay, no. J03798, version 1.0; Ortho-Clinical Diagnostics, Inc. Rochester, NY)
Confirmation:
The VITROS HBsAg Confirmatory Kit uses the principle of specific antibody neutralization to confirm the presence of HBsAg. The sample is tested twice: 1 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. J10583, version 1.0; Ortho-Clinical Diagnostics, Inc., Rochester, NY)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Sunday; Varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
87340-HBsAg
87341-HBsAg confirmation (if appropriate)
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| H_BAG | HBs Antigen, S | 5195-3 |
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