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Test Code HBC; SQ: HBCM Hepatitis B Virus Core Total Antibodies, Serum

Important Note

Includes both IgG and IgM

Reporting Name

HBc Total Ab, S

Useful For

Diagnosis of recent or past hepatitis B

 

Determination of occult hepatitis B in otherwise healthy hepatitis B virus carriers with negative test results for hepatitis B surface (HBs) antigen, anti-HBs, anti-HB core IgM, hepatitis Be (HBe) antigen, and anti-HBe

 

This assay is not useful for differentiating among acute, chronic, and past or resolved hepatitis B.

 

This test should not be used as a screening or confirmatory test for blood donor specimens.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum SST


Ordering Guidance


This test should not be used to screen or test pregnant individuals who may or may not have risk factors for hepatitis B virus (HBV) infection. For testing such patients, order HBCPR / Hepatitis B Virus Core Total Antibodies Prenatal, Serum.

 

This test should not be used to screen or test asymptomatic, non-pregnant individuals with or without risk factors for HBV. For testing such patients, order HBCSN / Hepatitis B Virus Core Total Antibodies Screen, Serum.

 

If a hepatitis B core total antibody test that reflexes to hepatitis B virus core IgM is needed, order test CORAB / Hepatitis B Virus Core Total Antibodies, with Reflex to Hepatitis B Virus Core Antibody IgM, Serum.



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
  Ambient  72 hours

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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HBC HBc Total Ab, S 13952-7

 

Result ID Test Result Name Result LOINC Value
HBC HBc Total Ab, S 13952-7

Clinical Information

Hepatitis B virus core antibodies (anti-HBc) appear shortly after the onset of symptoms of hepatitis B infection and soon after the appearance of hepatitis B virus surface antigen (HBsAg). Initially, anti-HBc consist almost entirely of the IgM antibody class, followed by appearance of anti-HBc IgG for which there is no commercial diagnostic assay.

 

The anti-HBc total antibody test, which detects both IgM and IgG antibodies, and the test for anti-HBc IgM may be the only markers of recent hepatitis B detectable in the "window period." The window period begins with the clearance of HBsAg and ends with the appearance of anti-HBs. Anti-HBc total may be the only serologic marker remaining years after exposure to hepatitis B virus.

 

This assay is US Food and Drug Administration-approved for in vitro diagnostic use and not for screening cell, tissue, and blood donors.

Interpretation

Negative hepatitis B virus core total antibody (anti-HBc total) test results indicate the absence of exposure to hepatitis B virus and no evidence of recent, past/resolved, or chronic hepatitis B.

 

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

 

Positive 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 anti-HBc IgM (HBIM / Hepatitis B Virus Core Antibody, IgM, Serum) is necessary to confirm an acute or recent infection.

 

Neonatal patients (<1 month old) with positive anti-HBc total results from this assay should be tested for anti-HBc IgM (HBIM / Hepatitis B Virus 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 for these neonatal patients.

Method Description

The Elecsys anti-HBc (hepatitis B virus core antibody) II assay is based on the competitive immunoassay principle and performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. Patient's sample is pretreated first with a reducing reagent, and after the addition of synthetic HBc antigen (HBcAg), complexes are formed with anti-HBc present in the sample. The remaining unbound sites on the HBcAg become occupied with the added biotinylated antibodies and ruthenium complex-labeled antibodies specific for HBcAg. The entire complex binds to the streptavidin-coated microparticles (solid phase) via interaction of biotin and streptavidin. The reaction mixture is then aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. After unbound substances are washed away, voltage is applied to the electrode that induces chemiluminescent emissions which are measured by a photomultiplier. The test result is determined by comparing the electrochemiluminescence signal generated from the reaction product in the sample to the cutoff index (COI) value set from reagent lot-specific assay calibration.(Package insert: Elecsys Anti-HBc II. Roche Diagnostics; v1.0, 04/2022)

Reject Due To

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

Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Secondary ID

8347

Forms

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

-Gastroenterology and Hepatology Test Request (T728)

-Infectious Disease Serology Test Request (T916)

Highlights

This diagnostic test should be used to test symptomatic individuals suspected with viral hepatitis.