Test Catalog

Test Id : CORAB

Hepatitis B Core Total Antibodies, with Reflex to Hepatitis B Core Antibody IgM, Serum

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 (HBsAg) and antibodies to HBsAg are negative

 

This test is not useful for determining immunity to or recovery from hepatitis B viral (HBV) infection.

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If hepatitis B core (HBc) total antibodies is positive, then HBc IgM is performed at an additional charge.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Chemiluminescence Immunoassay (CIA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

HBc Total Ab, w/Reflex, S

Aliases
Lists additional common names for a test, as an aid in searching

Anti Core Antibodies

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

CORAB

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If hepatitis B core (HBc) total antibodies is positive, then HBc IgM is performed at an additional charge.

Specimen Type
Describes the specimen type validated for testing

Serum SST

Necessary Information

Date of collection is required.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Patient Preparation: For 24 hours before specimen collection do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial within 24 hours.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send a Gastroenterology and Hepatology Client Test Request (T728) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.4 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 28 days
Refrigerated 7 days
Ambient 24 hours

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 (HBsAg) and antibodies to HBsAg are negative

 

This test is not useful for determining immunity to or recovery from hepatitis B viral (HBV) infection.

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If hepatitis B core (HBc) total antibodies is positive, then HBc IgM is performed at an additional charge.

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 anti-HBc IgM. 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

Interpretation
Provides information to assist in interpretation of the test results

Positive antibodies to hepatitis B core antigen (anti-HBc) total result may indicate recent, past/resolved, or chronic hepatitis B viral (HBV) infection.

 

Testing for anti-HBc IgM (HBIM / 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 (HBsAg) in the latter condition.

 

Negative anti-HBc total results indicate the absence of recent, past/resolved, or chronic hepatitis B. An inconclusive result for HBc total suggests presence of interfering substance in the patient's serum specimen.

 

Positive antibodies to 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
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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 >3000 mg/dL)

-Grossly hemolyzed (hemoglobin level of >500 mg/dL)

-Containing particulate matter

-Cadaveric specimen

-Heat-inactivated specimen

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Bonino F, Piratvisuth T, Brunetto MR, Liaw YF: Diagnostic markers of chronic hepatitis B infection and disease. Antivir Ther. 2010;15 Suppl 3:35-44. doi: 10.3851/IMP1622

2. Servoss JC, Friedman LS: Serologic and molecular diagnosis of hepatitis B virus. Clin Liver Dis. 2004 May;8(2):267-281. doi: 10.1016/j.cld.2004.02.001

3. Badur S, Akgun A: Diagnosis of hepatitis B infections and monitoring of treatment. J Clin Virol. 2001 Jun;21(3):229-237.

4. LeFebre ML, U.S. Preventive Services Task Force: Screening for hepatitis B virus infection in nonpregnant adolescents and adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Jul;161(1):58-66. doi:10.7326/M14-1018

5. Jackson K, Locarnini S, Gish R: Diagnostics of hepatitis B virus: Standard of care and investigational. Clin Liver Dis (Hoboken). 2018 Aug;12(1):5-11. doi: 10.1002/cld.729

6. Coffin CS, Zhou K, Terrault NA: New and old biomarkers for diagnosis and management of chronic hepatitis B virus infection. Gastroenterology. 2019 Jan;156(2):355-368. doi: 10.1053/j.gastro.2018.11.037

7. World Health Organization: WHO guidelines on hepatitis B and C testing. 2017. Accessed September 29, 2020. Available at www.who.int/hepatitis/publications/HEP17001_WEB11.pdf?ua=1

8. Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD, and TB Prevention: Testing and public health management of persons with chronic hepatitis B virus infection. Centers for Disease Control and Prevention. Updated October 8, 2019. Accessed April 8, 2020. Available at www.cdc.gov/hepatitis/hbv/testingchronic.htm

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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 a competitive immunoassay technique involving 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 system. The amount of HRP conjugate is indicative of the concentration of anti-HBc present in the sample.(Package insert: VITROS Anti-HBc Assay, no. GEM1211, version 14.1. Ortho-Clinical Diagnostics, Inc; 09/06/2019)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86704

86705 (if appropriate)

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports