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Determining infectivity of hepatitis B virus (HBV) carriers
Monitoring infection status of chronically HBV-infected patients
Monitoring serologic response of chronically HBV-infected patients who are receiving antiviral therapy
See HBV Infection-Diagnostic Approach and Management Algorithm in Special Instructions.
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.
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 lack of HBV replication.
See Viral Hepatitis Serologic Profile and HBV Infection-Diagnostic Approach and Management Algorithm in Special Instructions. In addition, see The Laboratory Approach to the Diagnosis and Monitoring of Hepatitis B Infection in Publications.
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 resolution of HBV infectivity.
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.
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 (triglyceride level >3,000 mg/dL)
-Grossly hemolyzed (hemoglobin level >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