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Interpretive Handbook

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Test 8347:
Hepatitis B Core Total Antibodies, Serum

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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.

Useful For Suggests clinical disorders or settings where the test may be helpful

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, anti-hepatitis B surface, anti-hepatitis 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.

Interpretation Provides information to assist in interpretation of the test results

A positive result indicates acute, chronic, or past/resolved hepatitis B.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This test is not offered as a screening or confirmatory test for blood donor specimens.

 

Positive anti-hepatitis 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/9015 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 method should be tested for anti-HBc IgM to rule out possible maternal anti-HBc total causing false-positive results. Repeat testing 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

-Cadaveric specimens

-Heat inactivated specimens

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

Interpretation depends on clinical setting.

See Viral Hepatitis Serologic Profiles in Special Instructions.

Clinical References Provides recommendations for further in-depth reading of a clinical nature

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