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HelpEpic 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 SSTAdditional 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.
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 daysReporting Name
HBe Antibody, SInterpretation
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 |
Alias: Hepatitis BE | Hep BE