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Epic Code LAB7960 Hepatitis B e Antibody, Serum

Additional Codes

Mayo Code: HEAB

Interface Order Alias: 10166

Epic: LAB 7960

Cerner: 8610

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Determining infectivity of hepatitis B virus (HBV) carriers

 

Monitoring infection status of individuals with chronic hepatitis B

 

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

 

Determining the level of hepatitis B e antibody

Specimen Type

Serum SST


Additional Testing Requirements


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


Patient Preparation: For 24 hours before specimen collection do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial within 24 hours.


Laboratory Test Directory Note:

COLLECTION NOTE: Volumes listed are in serum or plasma, draw approximately 2 1/2 times the requested volume in whole blood.

Specimen Minimum Volume

0.5 mL

Forms

If not ordering electronically, complete, print, and send a Gastroenterology and Hepatology Client Test Request (T728) with the specimen.

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 28 days
  Refrigerated  7 days
  Ambient  24 hours

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Cautions

Biotin (vitamin B7) is a common ingredient in multivitamins and dietary supplements to enhance hair, nail, and skin growth. Biotin can interfere with the assay performance and cause possible false-negative hepatitis B e-antigen (HBeAg) and false-positive HBe antibody (anti-HBe) results. Patients should be instructed to stop taking such multivitamins and dietary supplements for at least 24 hours prior to blood collection.

 

Appearance of anti-HBe in serum does not completely rule-out chronic hepatitis B carrier state or infectivity.

 

Performance characteristics of this assay have not been established in patients under the age of 2 or in populations of immunocompromised or immunosuppressed patients. This assay is 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 (triolein level of >3000 mg/dL)

-Grossly hemolyzed (hemoglobin level of >124 mg/dL)

Clinical Information

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

 

In hepatitis B virus (HBV) carriers and in patients with chronic hepatitis B, positive anti-HBe results usually indicate inactivity of the virus and low infectivity of the patients. Positive anti-HBe results in the presence of detectable HBV DNA in serum indicate active viral replication.

 

See the following in Special Instructions:

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

-Viral Hepatitis Serologic Profiles

 

Method Name

Chemiluminescence Immunoassay

Report Available

Same day/1 to 2 days

Reporting Name

HBe Antibody, S

Reference Values

Negative

See Viral Hepatitis Serologic Profiles in Special Instructions.

Interpretation

Absence of hepatitis B e antigen (HBeAg) with appearance of HBe antibody (anti-HBe) is consistent with inactivity of the virus and loss of hepatitis B virus (HBV) infectivity.

 

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

Method Description

This test is performed using a competitive technique, which involves preincubation of anti-hepatitis B e (anti-HBe) IgG in the patient sample with a fixed weight of hepatitis B e antigen in the assay reagent, followed by incubation with a conjugate reagent that contains biotinylated mouse monoclonal anti-HBe IgG and horseradish peroxidase (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_US_EN, version 9.1. Ortho-Clinical Diagnostics, Inc; 09/06/2019)

Day(s) Performed

Monday through Saturday

Clinical Reference

1. Bonino F, Piratvisuth T, Brunetto MR, Liaw YF: Diagnostic markers of chronic hepatitis B infection and disease. Antivir Ther. 2010;15(3):35-44

2. Servoss JC, Friedman LS: Serologic and molecular diagnosis of hepatitis B virus. Clin Liver Dis. 2004;8:267-281

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

4. WHO Guidelines Development Group: World Health Organization: Guidelines on hepatitis B and C testing. World Health Organization; 2017. Accessed September 29, 2020. Available at www.who.int/hepatitis/publications/guidelines-hepatitis-c-b-testing/en

5. LeFebre 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;161:58-66. doi:10.7326/M14-1018

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

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

8. Centers for Disease Control and Prevention. Testing and public health management of persons with chronic hepatitis B virus infection. Accessed April 8, 2020. Available at www.cdc.gov/hepatitis/hbv/testingchronic.htm

Test Classification

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

86707

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HEAB HBe Antibody, S 33463-1

 

Result ID Test Result Name Result LOINC Value
HEAB HBe Antibody, S 33463-1
Laboratory Test Directory Additional Information:

Alias: Hepatitis BE | Hep BE