Test Catalog

Test Id : HEAG

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Hepatitis B Virus e Antigen and Hepatitis B Virus e Antibody, Serum

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Overview

Test Catalog

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

Determining the presence or absence of detectable hepatitis B virus e antigen and antibody in monitoring infection status of individuals with chronic hepatitis B

 

Determining infectivity of hepatitis B virus (HBV) carriers

 

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 Id Reporting Name Available Separately Always Performed
EAG Hepatitis Be Ag, S Yes Yes
HEAB HBe Antibody, S Yes Yes

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

Electrochemiluminescence Immunoassay (ECLIA)

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

Hepatitis Be Ag and Ab, S

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

Hepatitis Be Profile

HEAG

HBe profile

Anti-HBe profile

HBe antigen profile

HBeAg profile

Specimen Type
Describes the specimen type validated for testing

Serum SST

Ordering Guidance

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

Additional Testing Requirements

 

Necessary Information

Date of collection is required

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

Patient Preparation: For 24 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).

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: 0.8 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.

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

Forms

If not ordering electronically, complete, print, and send 1 of the following:

-Gastroenterology and Hepatology Test Request (T728)

-Infectious Disease Serology Test Request (T916)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.7 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) 90 days
Refrigerated 6 days
Ambient 72 hours

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

Determining the presence or absence of detectable hepatitis B virus e antigen and antibody in monitoring infection status of individuals with chronic hepatitis B

 

Determining infectivity of hepatitis B virus (HBV) carriers

 

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

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

Hepatitis B virus (HBV) e antigen (HBeAg) is a small polypeptide, which exists in a free form in the serum of individuals during the early phase of hepatitis B infection, soon after hepatitis B virus surface antigen (HBsAg) becomes detectable. Serum levels of both HBeAg and HBsAg rise rapidly during the period of viral replication. The presence of HBeAg in serum correlates with viral infectivity, the number of infectious virions, and the presence of HBV core antigen in the infected hepatocytes.

 

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

 

In HBV carriers and patients with chronic hepatitis B, positive HBeAg results usually indicate presence of active HBV replication and high infectivity. A negative HBeAg result indicates very minimal or no HBV replication. Positive anti-HBe test results usually indicate inactivity of the virus and low infectivity, and such positive results in the presence of detectable HBV DNA in serum also 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

 

For more information see Viral Hepatitis Serologic Profiles.

Interpretation
Provides information to assist in interpretation of the test results

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

 

Absence of HBeAg with appearance of anti-HBe is consistent with loss of HBV infectivity.

 

Although resolution of chronic HBV infection generally follows the appearance of anti-HBe, 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

Serum specimens from individuals taking multivitamins containing biotin or biotin supplements of 20 mg or more per day may have false-negative hepatitis B virus e antigen (HBeAg) and false-positive HBe antibody (anti-HBe) results due to interference of biotin with the assay. Such individuals should stop taking these biotin-containing dietary supplements for a minimum of 12 hours before blood collection for this test.

 

Disappearance of HBeAg or appearance of anti-HBe in serum does not completely rule-out chronic hepatitis B virus carrier state or infectivity.

 

Performance characteristics of these 2 assays have not been established in patients younger than 2 years, pregnant women, or in populations of immunocompromised or immunosuppressed patients. These 2 assays are not licensed by US Food and Drug Administration 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 >25 mg/dL)

-Grossly lipemic (Intralipid level of >1000 mg/dL)

-Grossly hemolyzed (hemoglobin level of >2000 mg/dL)

-Specimen containing particulate matter

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

1. 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;161(1):58-66. doi:10.7326/M14-1018

2. Terrault NA, Bzowej NH, Chang KM, et al. AASLD guidelines for treatment of chronic hepatitis B. Hepatology. 2016; 63(1):261-283

3. WHO guidelines on hepatitis B and C testing. World Health Organization; 2017. Accessed December 21, 2023. Available at www.who.int/publications/i/item/9789241549981

4. Jackson K, Locarnini S, Gish R. Diagnostics of hepatitis B virus: Standard of care and investigational. Clin Liver Dis. 2018; 12(1):5-11. doi:10.1002/cld.729

5. Coffin CS, Zhou K, Terrault NA. New and old biomarkers for diagnosis and management of chronic hepatitis B virus infection. Gastroenterology. 2019; 156(2):355-368. doi:10.1053/j.gastro.2018.11.037

6. Conners EE, Panagiotakopoulos L, Hofmeister MG, et al. Screening and testing for hepatitis B virus infection: CDC Recommendations - United States, 2023. MMWR Recomm Rep. 2023;72(1):1-25

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

Hepatitis B Virus e Antigen:

The Elecsys HBeAg (hepatitis B e antigen) assay is based on the sandwich principle and performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. HBeAg present in patient's sample reacts with 2 biotinylated monoclonal anti-HBeAg antibodies and a mixture of monoclonal anti-HBeAg antibody and polyclonal anti-HBeAg antibodies labeled with a ruthenium complex react to form a sandwich complex. After addition of streptavidin-coated microparticles (solid phase), the complexes bind to this solid phase via interaction of biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then washed away, and voltage is applied to the electrode that induces chemiluminescent emissions, which are measured by a photomultiplier. The test result is determined by comparing the electrochemiluminescence signal generated from the patient's sample to the cutoff index (COI) value set from reagent lot-specific assay calibration.(Package insert: Elecsys HBeAg. Roche Diagnostics, v1.0, 10/2020) 

 

Hepatitis B Virus e Antibody:

The Elecsys Anti-HBe (hepatitis B virus e antibody) assay is based on the competitive immunoassay principle and performed using an electrochemiluminescence method on the automated cobas e 801 immunochemistry analyzer. Anti-HBe present in the patient's sample first binds to the added synthetic HBeAg. The remaining unbound sites on the synthetic HBeAg become occupied with the added biotinylated antibodies and ruthenium complex-labeled antibodies specific for HBeAg. The entire complex becomes bound to the streptavidin-coated microparticles (solid phase) via interaction of biotin and streptavidin. The reaction mixture is then aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then washed away, and voltage is applied to the electrode that induces chemiluminescent emissions, which are measured by a photomultiplier. Test result is determined by comparing the electrochemiluminescence signal generated from the sample to the COI value set from reagent lot-specific assay calibration.(Elecsys Anti-HBe. Roche Diagnostics; v1.0, 12/2021)

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 account representative. 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.

86707

87350

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
HEAG Hepatitis Be Ag and Ab, S 77176-6
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.
EAG Hepatitis Be Ag, S 13954-3
HEAB HBe Antibody, S 33463-1

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 | 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

Test Update Resources

Change Type Effective Date
Test Changes - Method 2024-04-18