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Test ID: HEAG
Hepatitis Be Antigen and Hepatitis Be Antibody, Serum

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

Yes

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

Determining infectivity of hepatitis B virus (HBV) carriers

 

Monitoring infection status of chronically HBV-infected patients

 

Monitoring serologic response of chronically HBV-infected patients receiving antiviral therapy

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 IDReporting NameAvailable SeparatelyAlways Performed
EAGHepatitis Be Ag, SYesYes
HEABHBe Antibody, SYesYes

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 (CIA)

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

Hepatitis Be Ag and Ab, S

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

Hepatitis Be Profile, Serum
HEPBE Profile, Serum

Specimen Type Describes the specimen type needed for testing

Serum SST

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: 1.5 mL

Collection Instructions: Spin down and immediately remove serum from clot.

Additional Information:

1. Date of draw is required.

2. If ordered with HBVQU / Hepatitis B Virus (HBV) DNA Detection and Quantification by Real-Time PCR, Serum; send separate vials.

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.

1 mL

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 TypeTemperatureTime
Serum SSTFrozen (preferred)
 Refrigerated 7 days
 Ambient 24 hours

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

Hepatitis Be antigen (HBeAg) is found in the early phase of hepatitis B infection soon after hepatitis Bs antigen becomes detectable. Serum levels of both antigens rise rapidly during the period of viral replication. The presence of HBeAg correlates with hepatitis B virus (HBV) infectivity, the number of viral Dane particles, the presence of core antigen in the nucleus of the hepatocyte, and presence of viral DNA polymerase in serum.

 

During recovery from acute hepatitis B, after HBeAg level declines and becomes undetectable, HBe antibody (anti-HBe) appears in the serum. Anti-HBe usually remains detectable for several years after recovery from acute infection.

 

In HBV carriers and chronic hepatitis B patients, positive HBeAg results usually indicate presence of active HBV replication and high infectivity. A negative HBeAg result indicates very minimal or lack of HBV replication. Positive anti-HBe results usually indicate inactivity of the virus and low infectivity. Positive anti-HBe results in the presence of detectable HBV DNA in serum indicate active viral replication in these patients.

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 BE ANTIGEN

Negative

 

HEPATITIS BE ANTIBODY

Negative

See Viral Hepatitis Serologic Profiles in Special Instructions.

Interpretation Provides information to assist in interpretation of the test results

Presence of hepatitis Be (HBe) antigen and absence of HBe antibody usually indicate active hepatitis B virus (HBV) replication and high infectivity.

 

Absence of HBe antigen with appearance of HBe antibody is consistent with loss of HBV infectivity.

 

Although resolution of chronic HBV infection generally follows appearance of HBe antibody, the HBV carrier state may persist.

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

Disappearance of hepatitis Be (HBe) antigen or appearance of HBe antibody in serum does not completely rule out chronic hepatitis B carrier state or infectivity.

 

Consider administration of hepatitis B immune globulin and hepatitis B vaccine to individuals who have been exposed to patient's blood and/or body fluids.

 

Performance characteristics of these 2 assays have not been established in patients under the age of 2 or in populations of immunocompromised or immunosuppressed patients. These 2 assays are not licensed by 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 (triglyceride level of >3,000 mg/dL)

-Grossly hemolyzed (hemoglobin level of >61 mg/dL)

-Specimen containing particulate matter

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 Jun;21(3):229-237

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

HBe Antigen (HBeAg) Assay:

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 horseradish peroxidase (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)

 

HBe Antibody (Anti-HBe) Assay:

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 horseradish peroxidase (HRP)-labeled 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)

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

No

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

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.

1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

3 days

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

See individual Unit Codes

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

Rochester

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.

This test has been cleared or approved by the U.S. 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 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

87350-Hepatitis Be antigen

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 IDReporting NameLOINC Code
EAGHepatitis Be Ag, S13954-3
HEABHBe Antibody, SIn Process