Clinical Summary

Hepatitis B virus e antigen (HBeAg) is found in the early phase of hepatitis B infection soon after hepatitis B virus 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.

CAUTIONS 
Disappearance of hepatitis B virus e antigen or appearance of HBe antibody in serum does not completely rule-out chronic hepatitis B carrier state or infectivity.

Specimens should not be taken from patients receiving therapy with high biotin doses (ie, >5 mg/day) until at least 8 hours following the last biotin administration.

Performance characteristics of this assay have not been established in patients younger than 2 years or in populations of immunocompromised or immunosuppressed patients. This assay is not licensed by US Food and Drug Administration 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 >40 mg/dL)

-Grossly lipemic (intralipid level >2200 mg/dL)

-Grossly hemolyzed (hemoglobin level >2200 mg/dL)

-Specimen containing particulate matter