Test ID: CORAB
Hepatitis B Core Total Antibodies, with Reflex to Hepatitis B Core Antibody, IgM, Serum
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
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
Detection and differentiation between recent and past/resolved or chronic hepatitis B viral (HBV) infection
Diagnosis of recent HBV infection during the "window period" when both hepatitis B surface antigen and antibodies to hepatitis B surface antigen are negative
Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HBIM | HBc IgM Ab, S | Yes | No |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
If hepatitis B core total antibodies is positive, then hepatitis B core antibody IgM is performed at an additional charge.
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-HBc
Anti-Hepatitis Bc
Antibody to Hepatitis Bc
Core Antibody IgG+IgM, S
HBV (Hepatitis B Virus)
Hep Bc Ab IgG/IgM, S
Hepatitis B Core Ab IgG and IgM Antibodies
Hepatitis B Core Ab IgG+IgM, S
Hepatitis B Core Total
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
During the course of a typical case of acute hepatitis B viral (HBV) infection, IgM antibodies to hepatitis B core antigen (anti-HBc IgM) 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 immunoglobulin M (IgM) anti-HBc. Anti-HBc IgM rises in level and is present during the core window period, ie, after hepatitis B surface antigen disappears and before antibodies to hepatitis B surface antigen appear. Anti-HBc total may be the only serologic marker remaining years after exposure to HBV.
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, antibodies to hepatitis B core antigen (anti-HBc) total result may indicate, either, recent, past/resolved, or chronic hepatitis B viral (HBV) infection.
Testing for anti-HBc IgM (HBIM/9015 Hepatitis B Core Antibody, IgM, Serum) 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 HBV infection. Differentiation between past/resolved and chronic hepatitis B can be based on the presence of hepatitis B surface antigen in the latter condition.
Negative anti-HBc total results indicate the absence of recent, past/resolved, or chronic hepatitis B.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Not useful for determining immunity to or recovery from hepatitis B viral (HBV) infection.
Positive antibodies to hepatitis B core antigen (anti-HBc) total results with negative anti-HBc IgM results in infants <18 months old may be due to passively acquired maternal IgG antibodies. Additional testing, such as hepatitis B surface antigen, anti-HBc IgM, and hepatitis Be antigen, are necessary to confirm a diagnosis of acute or recent hepatitis B in these infants.
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 matte
-Cadaveric specimen
-Heat-inactivated specimen
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 antibody to hepatitis B core antigen (anti-HBc) assay is performed using the VITROS Anti-HBc Calibrator on the VITROS ECi Immunodiagnostic System. A competitive immunoassay technique is used. This involves 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 are 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 is indicative of the concentration of anti-HBc present in the sample. (Package insert: Ortho aHBC, Ortho-Clinical Diagnostics, Rochester, NY 8/19/2009)
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 Saturday; 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-Hepatitis B core total
86705-Hepatitis B core, IgM (if appropriate)
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 |
|---|---|---|
| CORAB | HBc Total Ab, w/Reflex, S | 16933-4 |
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