|Values are valid only on day of printing.|
Determining infectivity of hepatitis B virus (HBV) carriers
Monitoring infection status of chronically HBV-infected patients
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 (CIA)
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 1.5 mL
Collection Instructions: Spin down and remove serum from gel within 24 hours.
1. Date of draw is required.
2. If ordered with HBVQU / Hepatitis B Virus (HBV) DNA Detection and Quantification by Real-Time PCR, Serum; send separate vials.
Mild OK; Gross reject
Mild OK; Gross reject
Mild OK; Gross reject
|Serum SST||Frozen (preferred)|
Hepatitis Be antigen (HBeAg) is found in the early phase of hepatitis B infection soon after hepatitis Bs 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 viral Dane particles, the presence of core antigen in the nucleus of the hepatocyte, and presence of viral DNA polymerase in serum.
During recovery from acute hepatitis B, after HBeAg level declines and becomes undetectable, HBe antibody (anti-HBe) appears in the serum. Anti-HBe usually remains detectable for several years after recovery from acute infection.
In HBV carriers and chronic hepatitis B patients, positive HBeAg results usually indicate presence of active HBV replication and high infectivity. A negative HBeAg result indicates very minimal or lack of 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 indicate active viral replication in these patients.
HEPATITIS BE ANTIGEN
HEPATITIS BE ANTIBODY
See Viral Hepatitis Serologic Profiles in Special Instructions.
Presence of hepatitis Be (HBe) antigen and absence of HBe antibody usually indicate active hepatitis B virus (HBV) replication and high infectivity.
Absence of HBe antigen with appearance of HBe antibody is consistent with loss of HBV infectivity.
Although resolution of chronic HBV infection generally follows appearance of HBe antibody, the HBV carrier state may persist.
Disappearance of hepatitis Be (HBe) antigen or appearance of HBe antibody in serum does not completely rule out chronic hepatitis B carrier state or infectivity.
Consider administration of hepatitis B immune globulin and hepatitis B vaccine to individuals who have been exposed to patient's blood and/or body fluids.
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 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 (triglyceride level of >3,000 mg/dL)
-Grossly hemolyzed (hemoglobin level of >61 mg/dL)
-Specimen containing particulate matter
1. Servoss JC, Friedman LS: Serologic and molecular diagnosis of hepatitis B virus. Clin Liver Dis 2004;8:267-281
2. Badur S, Akgun A: Diagnosis of hepatitis B infections and monitoring of treatment. J Clin Virol 2001 Jun;21(3):229-237
HBe Antigen (HBeAg) Assay:
This test is performed using the FDA-approved VITROS HBeAg Reagent Pack and the Immunodiagnostic Product HBeAg Calibrator on the VITROS ECi/ECiQ Immunodiagnostic System based on chemiluminescence immunoassay principle. An immunometric technique is used. This involves the simultaneous reaction of 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, 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, version 3.0; Ortho-Clinical Diagnostics, Rochester, NY 14626-5101)
HBe Antibody (Anti-HBe) Assay:
This test is performed using the FDA-approved VITROS Anti-HBe Reagent Pack and the VITROS Anti-HBe Calibrator on the VITROS ECi/ECiQ Immunodiagnostic Systems based on chemiluminescence immunoassay principle. A competitive technique is used which involves pre-incubation 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 horseradish peroxidase (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 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, version 1.0; Ortho-Clinical Diagnostics, Rochester, NY 14626-5101, 7/20/2011)
Monday through Saturday
86707-Hepatitis Be antibody
87350-Hepatitis Be antigen
|Result ID||Test Result Name||Result LOINC Code|
|EAG||Hepatitis Be Ag, S||13954-3|
|HEAB||HBe Antibody, S||In Process|