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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.
During recovery from acute hepatitis B, the hepatitis Be antigen level declines and becomes undetectable and hepatitis Be 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 HBV Infection-Diagnostic Approach and Management Algorithm and Viral Hepatitis Serologic Profile in Special Instructions. Also see The Laboratory Approach to the Diagnosis and Monitoring of Hepatitis B Infection in Publications.
See Viral Hepatitis Serologic Profiles in Special Instructions.
Absence of hepatitis Be (HBe) antigen with appearance of HBe antibody is consistent with loss of hepatitis (HBV) infectivity.
Although resolution of chronic HBV infection generally follows appearance of HBe antibody, the HBV carrier state may persist.
Appearance of hepatitis Be 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 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 >124 mg/dL)
-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