Determining the presence or absence of detectable hepatitis B 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
Test Id | Reporting Name | Available Separately | Always Performed |
---|---|---|---|
EAG | Hepatitis Be Ag, S | Yes | Yes |
HEAB | HBe Antibody, S | Yes | Yes |
Chemiluminescence Immunoassay
Hepatitis Be Profile
HEAG
HBe profile
Anti-HBe profile
HBe antigen profile
HBeAg profile
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: 1.5 mL
Collection Instructions:
1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot serum into plastic vial.
If not ordering electronically, complete, print, and send 1 of the following:
1 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 the presence or absence of detectable hepatitis B 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
Hepatitis B e antigen (HBeAg) is a small polypeptide that exists in a free form in the serum of individuals during the early phase of hepatitis B infection, soon after HB 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 hepatitis B virus (HBV) 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 hepatitis B e 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 results usually indicate inactivity of the virus and low infectivity. Positive anti-HBe results in the presence of detectable HBV DNA in serum also indicate active viral replication in these patients.
HEPATITIS Be ANTIGEN:
Negative
HEPATITIS Be ANTIBODY:
Negative
Presence of hepatitis B 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.
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.
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 these 2 assays have not been established in patients under the age of 2 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 >20 mg/dL)
-Grossly lipemic (triolein level of >3000 mg/dL)
-Grossly hemolyzed (hemoglobin level of >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 May;8(2):267-281
3. Terrault NA, Bzowej NH, Chang KM, Hwang JP, Jonas MM, Murad MH: AASLD guidelines for treatment of chronic hepatitis B. Hepatology. 2016 Jan;63(1):261-283
4. WHO Guidelines Development Group: World Health Organization: Guidelines on hepatitis B and C testing. World Health Organization; 2017 Accessed September 9, 2022. Available at www.who.int/publications/i/item/9789241549981
5. 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 Jul 1;161(1):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 Aug 22;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. Gastroenterology. 2019 Jan;156(2):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. Updated March 28, 2022. Accessed September 9, 2022. Available at www.cdc.gov/hepatitis/hbv/testingchronic.htm
Hepatitis B e antigen Assay:
This test is performed using tan immunometric technique is used. This involves the simultaneous reaction of hepatitis B e antigen (HBeAg) in the sample with biotinylated mouse monoclonal HBe antibody (anti-HBe) and horseradish peroxidase (HRP)-labeled mouse monoclonal anti-HBe 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 are 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. Ortho-Clinical Diagnostics, Inc; Version 10.0, 04/08/2020)
Hepatitis Be antibody Assay:
This test is performed using a competitive technique, which involves preincubation of anti-HBe IgG in the sample with a fixed weight of HBeAg in the assay reagent, followed by incubation with a conjugate reagent that contains biotinylated mouse monoclonal anti-HBe IgG and HRP-labeled 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 are 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. Ortho-Clinical Diagnostics, Inc; Version 9.1, 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.
86707
87350
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 |