Test ID: HBC
Hepatitis B Core Total Antibodies, Serum
NY State Approved 
Indicates the status of NY State approval and if the test is orderable for NY State clients.
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.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
Chemiluminescence Immunoassay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Anti-Hepatitis Bc
Antibody to Hepatitis Bc
Core Antibody IgG/IgM, S performed at Mayo New England
HBV (Hepatitis B Virus)
Hep B Core Ab IgG/IgM, S performed at Mayo New England
Hep Bc Ab IgG/IgM, S performed at Mayo New England
Hepatitis B Core Ab IgG and IgM, S
Hepatitis B Virus (HBV)
Hepatitis Bc
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Collection Instructions: Spin down and remove serum from clot within 24 hours.
Additional Information: Date of draw is required.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross reject |
| Lipemia | Mild OK; Gross reject |
| Icterus | Mild OK; Gross reject |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum SST | Frozen (preferred) | |
| Refrigerated | 7 days | |
| Ambient | 24 hours | |
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.
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.
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
Clinical Reference 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
Method Description Describes how the test is performed and provides a method-specific reference
The VITROS anti-hepatitis B core (anti-HBc) assay is a competitive immunoassay method based on the reaction of anti-HBc in the sample with hepatitis B core antigen (HBcAg)-coated wells. Unbound sample is removed by washing. Horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-HBc) is then allowed to react with the remaining exposed HBcAg on the well surface. Unbound conjugate is removed by washing.
The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The light signals are read by the VITROS ECi System. The amount of HRP conjugate bound is indicative of the concentration of anti-HBc present in the sample. (Package insert: VITROS Anti-HBc Assay, no. J20866, version 2.0; Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626-5101)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Sunday; Varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
86704
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| HBC | HBc Total Ab, S | 22327-1 |
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