Test Catalog

Test Id : EAG

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Hepatitis B Virus e Antigen, 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 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

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

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, S

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

HBeAg

Hepatitis Be Ag

HBe Ag

HBe antigen

Hepatitis Be antigen

EAG

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

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.

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: 0.7 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 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.

0.6 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
Heat-inactivated specimen 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 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

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

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

Hepatitis B virus e antigen (HBeAg) is found in the early phase of hepatitis B infection soon after hepatitis B virus surface 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 infectious virions, and the presence of HBV core antigen in the infected hepatocytes.

 

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.

 

For more information, see the following:

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

-Viral Hepatitis Serologic Profiles

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

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.

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

This assay has not been licensed by the US Food and Drug Administration for testing cord blood specimens or screening donors of blood, plasma, human cell, or tissue products.

 

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination, and other findings.

 

Specimens should not be taken from patients receiving therapy with high biotin doses (ie, >5 mg/day) until at least 8 hours following the last biotin administration.

 

Drug interference studies were performed in vitro and may not assess the potential interferences that might be seen after the drugs are metabolized in vivo.

 

A reactive hepatitis B virus e antigen (HBeAg) result does not exclude co-infection by another hepatitis virus. False positive results due to non-specific reactivity cannot be ruled out with the Elecsys HBeAg assay. In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.

 

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

 

A non-reactive test result does not exclude the possibility of exposure to hepatitis B virus. Negative HBeAg results may occur during early infection due to delayed seroconversion. False negative results may occur due to antigen levels below the detection limit of this assay or if the patient’s antigen does not react with the antibody used in this test.

 

Results obtained with the Elecsys HBeAg assay may not be used interchangeably with values obtained with different manufacturers’ assay methods.

 

Performance characteristics of this assay have not been established in pregnant women, or in populations of immunocompromised or immunosuppressed patients.

 

Assay performance characteristics have not been stablished for the following specimen characteristics or specimen types:

-Grossly icteric (total bilirubin level >40 mg/dL)

-Grossly lipemic (intralipid level >2200 mg/dL)

-Grossly hemolyzed (hemoglobin level >2200 mg/dL)

-Specimen containing particulate matter

-Heat-inactivated specimens

-Specimens stabilized with azide

-Specimen types other than serum

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. Geneva: World Health Organization; February 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

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, which induces chemiluminescent emission that is measured by a photomultiplier. Test result is determined by comparing the electrochemiluminescence signal generated from the patient’s sample to the cutoff index value set from reagent lot-specific assay calibration.(Package insert: Elecsys HBeAg. Roche Diagnostics; v1.0, 10/2020)

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.

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.

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
EAG Hepatitis Be Ag, S 13954-3
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

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