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Test Code HBIM Hepatitis B Virus Core IgM Antibody, Serum

Reporting Name

HBc IgM Ab, S

Useful For

Diagnosis of acute hepatitis B virus (HBV) infection

 

Identifying acute HBV infection in the serologic window period when hepatitis B virus surface antigen and hepatitis B virus surface antibody results are negative

 

Differentiation between acute, chronic, or past HBV infections in the presence of positive hepatitis B virus core total antibodies

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum SST


Necessary Information


Date of collection is required.



Specimen Required


Patient Preparation: For 24 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Serum gel (red-top tubes are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 0.6 mL

Collection Instructions:

1. Centrifuge blood collection tube per manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot serum into a plastic tube.


Specimen Minimum Volume

0.6 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 90 days
  Refrigerated  6 days

Day(s) Performed

Monday through Saturday

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

86705

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HBIM HBc IgM Ab, S 24113-3

 

Result ID Test Result Name Result LOINC Value
HBIM HBc IgM Ab, S 24113-3

Clinical Information

Hepatitis B virus (HBV) is a DNA virus that is endemic throughout the world. In the initial (acute) phase of infection, hepatitis B virus core antibodies (anti-HBc) consist almost entirely of the IgM antibody class and appear shortly after the onset of symptoms. Anti-HBc IgM can be detected in serum and is usually present for up to 6 months after acute HBV infection. Anti-HBc IgM may be the only serologic marker of a recent hepatitis B infection detectable following the disappearance of hepatitis B surface antigen and prior to the appearance of hepatitis B virus surface antibody (ie, serologic window period).

Cautions

This assay has not been licensed by the US Food and Drug Administration  for the screening of blood, plasma, and tissue donors.

 

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination, and other findings.

 

Serum specimens from individuals taking biotin supplements of 20 mg or more per day may have false-negative hepatitis B core antibody (anti-HBc) IgM test results due to interference of biotin with the assay. Such individuals should stop taking these biotin-containing dietary supplements for a minimum of 12 hours before blood collection for this test.

 

Current methods for the detection of IgM antibodies to HBc may not detect all infected individuals. A nonreactive test result does not exclude the possibility of exposure to HBV. In rare cases, interference due to high titers of antibodies to immunological components, streptavidin or ruthenium can occur.

 

The predictive value of a positive HBc IgM antibody test result is low when used to test specimens from patients with low prevalence of acute hepatitis B virus infection.

 

Results obtained with the Elecsys Anti-HBc IgM immunoassay may not be used interchangeably with values obtained with different manufacturers’ assay methods.

 

Assay performance characteristics have not been established for the following specimen characteristics or specimen types:

-Patients younger than 21 years, pregnant women, or in populations of immunocompromised or immunosuppressed patients

-Grossly icteric (total bilirubin level of >25 mg/dL)

-Grossly lipemic (Intralipid level of >1000 mg/dL)

-Grossly hemolyzed (hemoglobin level of >2000 mg/dL)

-Containing particulate matter

-Cadaveric specimens

-Specimen types other than serum

Report Available

Same day/1 to 2 days

Specimen Retention Time

14 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Forms

If not ordering electronically, complete, print, and send 1 of the following:

-Gastroenterology and Hepatology Test Request (T728)

-Infectious Disease Serology Test Request (T916)

Secondary ID

9015