Test ID: CHSBP
Chronic Hepatitis Profile (Type B)
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
Evaluating patients with suspected or confirmed chronic hepatitis B
Monitoring hepatitis B viral infectivity
Profile Information A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HBAG | HBs Antigen, S | Yes | Yes |
| EAG | Hepatitis Be Ag, S | Yes | Yes |
| HEAB | HBe Antibody, S | Yes | Yes |
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 HBs antigen is reactive, then HBs antigen confirmation will be performed at an additional charge.
See HBV Infection-Diagnostic Approach and Management Algorithm in Special Instructions.
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
Chemiluminescence 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
HBV (Hepatitis B Virus)
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: 2.5 mL
Collection Instructions: Spin down and remove serum from clot
Additional Information:
1. Date of draw is required.
2. Indicate "Type B."
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 | Plasma |
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 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 by drug addicts. The virus is also found in virtually every type of human body fluid and 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.
After a course of acute illness, HBV persists in approximately 10% of patients. Some of these carriers are asymptomatic; others develop chronic liver disease including cirrhosis and hepatocellular carcinoma.
See HBV Infection–Diagnostic Approach and Management Algorithm and Viral Hepatitis Serologic Profile in Special Instructions.
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.
HEPATITIS B SURFACE ANTIGEN
Negative
HEPATITIS Be ANTIGEN
Negative
HEPATITIS Be ANTIBODY
Negative
Interpretation depends on clinical setting. See Viral Hepatitis Serologic Profiles in Special Instructions.
Interpretation Provides information to assist in interpretation of the test results
Hepatitis B surface antigen (HBsAg) is the first serologic marker appearing in the serum 6 to 16 weeks following hepatitis B viral (HBV) infection. In acute cases, HBsAg usually disappears 1 to 2 months after the onset of symptoms. Persistence of HBsAg for more than 6 months indicates development of either chronic carrier state or chronic liver disease.
Hepatitis B surface antibody (anti-HBs) appears with the resolution of HBV infection after the disappearance of HBsAg. Anti-HBs also appears as the immune response following a course of inoculation with the hepatitis B vaccine.
Hepatitis B core antibody (anti-HBc) appears shortly after the onset of symptoms of HBV infection and may be the only serologic marker remaining years after exposure to hepatitis B.
The presence of hepatitis B envelope antigen (HBeAg) correlates with infectivity, the number of viral Dane particles, the presence of core antigen in the nucleus of the hepatocyte, and the presence of viral DNA polymerase in serum. Hepatitis B envelope antibody (anti-HBe) positivity in a carrier is often associated with chronic asymptomatic infection.
If the patient has a sudden exacerbation of disease, consider ordering hepatitis C virus antibody and hepatitis delta virus antibody (anti-HDV).
If HBsAg converts to negative and patient's condition warrants, consider testing for anti-HBs.
If HBsAg is positive, consider testing for anti-HDV.
See HBV Infection–Diagnostic Approach and Management Algorithm and Viral Hepatitis Serologic Profile in Special Instructions.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Positive hepatitis B surface antigen (HBsAg) test results should be reported by the attending physician to the State Department of Health, as required by law in some states.
Consider administration of hepatitis B immune globulin and hepatitis B vaccine to individuals exposed to the patient's blood and/or body fluids.
Performance characteristics of these assays have not been established in patients under the age of 2 or in populations of immunocompromised or immunosuppressed patients. These assays are not licensed by the FDA for testing cord blood samples or screening donors of blood, plasma, human cell, or tissue products.
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 >61 mg/dL)
-Containing particulate matter
-Cadaveric specimen
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Mahoney FJ: Update on diagnosis, management, and prevention of hepatitis B virus infection. Clin Microbiol Rev 1999;12:351-366
2. Gane E: Chronic hepatitis B virus infection in south Auckland. N Z Med J 1998;111:120-123
3. Gitlin N: Hepatitis B: diagnosis, prevention, and treatment. Clin Chem 1997;43:1500-1506
Method Description Describes how the test is performed and provides a method-specific reference
Hepatitis B Surface Antigen (HBsAg):
Specimens are first tested by the VITROS 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. 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)
HBsAg 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)
Hepatitis Be Antigen (HBeAg):
This test is performed using the FDA-approved VITROS HBeAg Reagent Pack and the Immunodiagnostic Product HBeAg Calibrator on the VITROS ECi/ECiQ Immunodiagnostic System based on chemiluminescence immunoassay principle. An immunometric technique is used. This involves the simultaneous reaction of HBeAg in the sample with biotinylated mouse monoclonal HBeAg antibody and HRP-labeled mouse monoclonal HBeAg antibody in the conjugate. The immune complex is captured by streptavidin on the wells; unbound materials are removed by washing. The bound HRP conjugate is measured by a luminescent reaction. 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 (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of HRP conjugate bound is indicative of the level of HBeAg present in the sample.(Package insert: VITROS Immunodiagnostic Product HBeAg Reagent Pack, No. GEM1222, version 1.0, Ortho-Clinical Diagnostics, Rochester, NY 14626-5101, 5/24/2011)
Hepatitis Be Antibody (Anti-HBe):
This test is performed using the FDA-approved VITROS Anti-HBe Reagent Pack and the VITROS Anti-HBe Calibrator on the VITROS ECi/ECiQ Immunodiagnostic Systems based on chemiluminescence immunoassay principle. A competitive technique is used which involves pre-incubation of anti-HBe IgG in the sample with a fixed weight of HBeAg in the assay reagent, followed by incubation with a conjugate reagent that contains biotinylated mouse monoclonal anti-HBe IgG and HRP-labelled mouse monoclonal anti-HBe IgG. The immune complex is captured by streptavidin on the wells. Unbound materials are removed by washing. The bound HRP conjugate is measured by a luminescent reaction. 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 (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of HRP conjugate bound is indicative of the level of anti-HBe IgG present in the sample.(Package insert: VITROS Immunodiagnostic Product Anti-HBe Reagent Pack, No. GEM1223, version 1.0, Ortho-Clinical Diagnostics, Rochester, NY 14626-5101, 7/20/2011)
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 Saturday; 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
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
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.
86707-Hepatitis Be antibody
87340-Hepatitis B surface antigen
87350-Hepatitis Be antigen
87341-Hepatitis B surface antigen 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 |
|---|---|---|
| EAG | Hepatitis Be Ag, S | In Process |
| HEAB | HBe Antibody, S | In Process |
| H_BAG | HBs Antigen, S | 5195-3 |
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