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Test Code CORAB Hepatitis B Virus Core Total Antibodies, with Reflex to Hepatitis B Virus Core IgM Antibody, Serum

Reporting Name

HBc Total Ab, w/Reflex, S

Useful For

Detection and differentiation between recent, past/resolved, or chronic hepatitis B

 

Diagnosis of recent hepatitis B virus (HBV) infection during the "window period" when both hepatitis B surface (HBs) antigen and anti-HBs are negative

 

This test is not useful for determining immunity to or recovery from HBV infection.

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HBIM HBc IgM Ab, S Yes No

Testing Algorithm

If the hepatitis B virus core (HBc) total antibodies test result is positive, then anti-HBc IgM is performed at an additional charge.

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: 0.7 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 vial.


Specimen Minimum Volume

0.6 mL

Specimen Stability Information

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

Special Instructions

Reference Values

Negative

Interpretation depends on clinical setting.

 

See Viral Hepatitis Serologic Profiles

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

86704

86705 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CORAB HBc Total Ab, w/Reflex, S 13952-7

 

Result ID Test Result Name Result LOINC Value
CORAB HBc Total Ab, w/Reflex, S 13952-7

Clinical Information

During the course of a typical case of acute hepatitis B, hepatitis B virus (HBV) core IgM antibodies (anti-HBc IgM) to hepatitis B virus core antigen are present in the serum shortly before clinical symptoms appear. Anti-HBc total is detectable during the prodromal, acute, and early convalescent phases when it exists as anti-HBc IgM. Anti-HBc IgM increase in level and are present during the core window period (ie, after hepatitis B virus surface (HBs) antigen disappears and before anti-HBs appear). Anti-HBc total may be the only serologic marker remaining years after exposure to HBV.

Interpretation

Negative hepatitis B virus core total antibody (anti-HBc total) results indicate the absence of recent, past/resolved, or chronic hepatitis B.

 

Positive anti-HBc total result may indicate recent, past/resolved, or chronic hepatitis B.

 

Testing for anti-HBc IgM is necessary to confirm the presence of acute or recent hepatitis B. A positive anti-HBc total result with a negative anti-HBc IgM result indicates past or chronic hepatitis B virus (HBV) infection. Differentiation between past/resolved and chronic hepatitis B can be based on the presence of hepatitis B virus surface antigen (HBsAg) in the latter condition.

 

Positive anti-HBc total results with negative anti-HBc IgM results in infants younger than 18 months may be due to passively acquired maternal IgG antibodies. Additional testing, such as HBsAg, anti-HBc IgM, and hepatitis Be antigen, are necessary to confirm a diagnosis of acute or recent hepatitis B in these infants.

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-positive hepatitis B core total antibody 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 antibodies to HBc may not detect all infected individuals. A nonreactive test result does not exclude the possibility of exposure to hepatitis B virus. In rare cases, interference due to high titers of antibodies to immunological components, streptavidin or ruthenium can occur.

 

Specimens containing sodium azide may cause false-positive results and should not be tested. Lipemic and precipitated samples may give inconsistent results.

 False positive results may also occur in a limited number of patients positive for antibodies to hepatitis C virus, hepatitis E virus, human T-cell lymphotropic virus, and human immunodeficiency virus. A reactive anti-HBc result does not exclude co-infection by another hepatitis virus.

 

Negative anti-HBc results may occur during early infection due to delayed seroconversion or low 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.

 

Results obtained with the Elecsys Anti-HBc II 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 >800 mg/dL)

-Containing particulate matter

-Cadaveric specimens

-Heat-inactivated specimens

-Specimen types other than serum

Report Available

1 to 3 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject
Heat-inactivated specimen 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)