|Values are valid only on day of printing.|
Diagnosis of recent or past hepatitis B infection
Determination of occult hepatitis B infection in otherwise healthy hepatitis B virus (HBV) carriers with negative test results for hepatitis B surface antigen, antihepatitis B surface, antihepatitis B core IgM, hepatitis Be antigen, and anti-HBe.
This assay is not useful for differentiating among acute, chronic, and past/resolved hepatitis B infection.
This assay is FDA-approved for in vitro diagnostic use and not for screening cell, tissue, and blood donors.
Hepatitis B core antibodies (anti-HBc Ab) appear shortly after the onset of symptoms of hepatitis B infection and soon after the appearance of hepatitis B surface antigen (HBsAg). Initially, anti-HBc Ab consist almost entirely of the IgM class, followed by appearance of anti-HBc IgG, for which there is no commercial diagnostic assay.
The anti-HBc total antibodies test, which detects both IgM and IgG antibodies, and the test for anti-HBc IgM antibodies may be the only markers of a recent hepatitis B infection detectable in the "window period." The window period begins with the clearance of HBsAg and ends with the appearance of antibodies to hepatitis B surface antigen (anti-HBs Ab). Anti-HBc total Ab may be the only serologic marker remaining years after exposure to hepatitis B.
Interpretation depends on clinical setting.
See Viral Hepatitis Serologic Profiles in Special Instructions.
A positive result indicates acute, chronic, or past/resolved hepatitis B.
This test is not offered as a screening or confirmatory test for blood donor specimens.
Positive antihepatitis B core (anti-HBc) total test results should be correlated with the presence of other hepatitis B virus serologic markers, elevated liver enzymes, clinical signs and symptoms, and a history of risk factors.
If clinically indicated, testing for HBIM / Hepatitis B Core Antibody, IgM, Serum is necessary to confirm an acute or recent infection.
Neonates (<1 month old) with positive anti-HBc total results from this assay should be tested for anti-HBc IgM (HBIM / Hepatitis B Core Antibody, IgM, Serum) to rule out possible maternal anti-HBc causing false-positive results. Repeat testing using this assay for anti-HBc total within 1 month is also recommended in these neonates.
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 >3,000 mg/dL)
-Grossly hemolyzed (hemoglobin level of >500 mg/dL)
-Containing particulate matter
1. Badur S, Akgun A: Diagnosis of hepatitis B infections and monitoring of treatment. J Clin Virol 2001;21(3):229-237
2. Servoss JC, Friedman LS: Serologic and molecular diagnosis of hepatitis B virus. Clin Liver Dis 2004;8(2):67-281