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 Be antigen
Chemiluminescence Immunoassay
HBeAg
Hepatitis Be Ag
HBe Ag
HBe antigen
Hepatitis Be antigen
EAG
Serum SST
If ordered with HBVQN / Hepatitis B Virus (HBV) DNA Detection and Quantification by Real-Time PCR, Serum; send separate vials.
Date of collection is 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.
If not ordering electronically, complete, print, and send a Gastroenterology and Hepatology Client Test Request (T728) with the specimen.
0.5 mL
Gross hemolysis | Reject |
Gross lipemia | Reject |
Gross icterus | Reject |
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Serum SST | Frozen (preferred) | 28 days | |
Refrigerated | 7 days | ||
Ambient | 24 hours |
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 Be antigen
Hepatitis Be antigen (HBeAg) is found in the early phase of hepatitis B infection soon after hepatitis B 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.
See the following in Special Instructions:
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Negative
See Viral Hepatitis Serologic Profiles in Special Instructions.
Presence of hepatitis Be 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.
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 Be antigen (HBeAg) and false-positive anti-HBe results. Patients should be instructed to stop taking such multivitamins and dietary supplements for at least 24 hours prior to blood collection.
Disappearance of HBeAg or 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 specimens 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 >20 mg/dL)
-Grossly lipemic (triolein level >3000 mg/dL)
-Grossly hemolyzed (hemoglobin level >61 mg/dL)
-Specimen containing particulate matter
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. 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
5. 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.
6. Coffin CS, Zhou K, Terrault NA: New and old biomarkers for diagnosis and management of chronic hepatitis B virus infection. Gastroenterol. 2019;156:355-368doi: 10.1053/j.gastro.2018.11.037.
7. 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/
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
This test is performed using an immunometric technique involving the simultaneous reaction of hepatitis B e antigen (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, and 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_US_EN, version 9.1. Ortho-Clinical Diagnostics, Inc; 09/06/2019)
Monday through Saturday
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.
87350
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 |