Plasma

Call laboratory for additional acceptable specimen collection containers.

3 mL whole blood from light green top tube or TWO Microtainer^® devices for pediatric patients

24 hrs/day, 7 days a week, including holidays.

1 hour (upon receipt in laboratory)

See Interpretive Data

A negative result of <0.90 indicates that IgM anti-HBc antibodies were not detected in the sample. A negative test result does not exclude the possibility of exposure to or infection with HBV.

A positive result of >1.10 indicates presumptive evidence of hepatitis B virus infection. IgM anti-HBc antibodies were detected in the sample which suggests either on-going or previous HBV infection.

This assay may be significantly impacted by high-dose biotin (>5 mg dose) taken within previous 12 hours. High concentrations of biotin may lead to falsely decreased results. These concentrations may be found in patients taking over-the-counter supplements with biotin content much higher than nutritional requirements for biotin. Specimens should not be collected until at least 12 hours after the last dose.

Current methods for the detection of IgM anti-HBc may not detect all infected individuals. False negative results may occur due to antibody levels below the detection limit of this assay or if the patient's antibodies do not react with the antigen used in this test. A positive anti-HBc IgM result does not exclude co-infection by another hepatitis virus.

The assay is limited to the detection of IgM anti-HBc in human serum or plasma. It can be used to determine whether a patient has, or has recently had, acute or subclinical hepatitis B infection. Supportive clinical information, including other hepatitis B markers, should also be evaluated. The test cannot determine a patient's immune status to hepatitis B.

The assay is unaffected by icterus < 25 mg/dL, hemolysis (Hb < 2000 mg/dL, or lipemia < 1000 mg/dL.

Electrochemiluminescence Immunoassay

86705

See Additional Information:
Biotin Interference with Immunoassays