Test Id : HBCSN
Hepatitis B Virus Core Total Antibodies Screen, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
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-hepatitis B core IgM, hepatitis Be (HBe) antigen, and HBe antibody
This assay is not useful for differentiating between acute, chronic, past, or resolved hepatitis B.
This test should not be used as a screening or confirmatory test for blood donor specimens.
Highlights
This test should be used to screen or test asymptomatic, nonpregnant individuals with or without risk factors for hepatitis B virus infection.
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Method Name
A short description of the method used to perform the test
Electrochemiluminescence Immunoassay (ECLIA)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Anti Core Antibodies screen
Anti-Hepatitis Bc screen
Antibody to Hepatitis Bc screen
HBC screen
HBV (Hepatitis B Virus) screen
Hepatitis B Core Ab IgG and IgM, S screen
Hepatitis B Virus (HBV) screen
Hepatitis Bc screen
HBCSN
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Specimen Type
Describes the specimen type validated for testing
Serum SST
Ordering Guidance
This test should not be used to test symptomatic individuals (ie, diagnostic purposes) suspected with viral hepatitis. For testing such patients with or without risk factors for hepatitis B virus (HBV) infection, order HBC / Hepatitis B Virus Core Total Antibodies, Serum.
This test should not be used to screen or test pregnant individuals with or without risk factors for HBV. For testing such patients, order HBCPR / Hepatitis B Virus Core Total Antibodies Prenatal, Serum.
If a hepatitis B core total antibody test that reflexes to hepatitis B core IgM is needed, order 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
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
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.
Special Instructions
Library of PDFs including pertinent information and forms related to the test
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)
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
0.6 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 |
| Heat-inactivated specimen | 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) | 90 days | |
| Ambient | 72 hours | ||
| Refrigerated | 6 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
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-hepatitis B core IgM, hepatitis Be (HBe) antigen, and HBe antibody
This assay is not useful for differentiating between acute, chronic, past, or resolved hepatitis B.
This test should not be used as a screening or confirmatory test for blood donor specimens.
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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 the appearance of anti-HBc IgG for which there is no commercial diagnostic assay.
The 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 may be the only serologic marker remaining years after exposure to hepatitis B virus (HBV).
This assay is US Food and Drug Administration approved for in vitro diagnostic use and not for screening cell, tissue, and blood donors.
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.
Interpretation
Provides information to assist in interpretation of the test results
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.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
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 (HBc) 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.
Drug interference studies were performed in vitro and may not assess the potential interferences that might be seen after the drugs are metabolized in vivo.
False positive results were observed in a limited number of patients positive for hepatitis C virus, hepatitis E virus, human T cell lymphotropic virus, and HIV.
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.
False negative results may occur due to 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.
False positive results due to non-specific reactivity cannot be ruled out with the Elecsys Anti-HBc II assay.
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
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. LeFevre 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;161(1):58-66. doi:10.7326/M14-1018
2. WHO guidelines on hepatitis B and C testing. Geneva: World Health Organization; February 2017. Accessed December 20, 2023. Available at www.who.int/publications/i/item/9789241549981
3. Jackson K, Locarnini S, Gish R. Diagnostics of hepatitis B virus: Standard of care and investigational. Clin Liver Dis. 2018;12(1):5-11. doi:10.1002/cld.729
4. Coffin CS, Zhou K, Terrault NA. New and old biomarkers for diagnosis and management of chronic hepatitis B virus infection. Gastroenterology. 2019;156(2):355-368. doi:10.1053/j.gastro.2018.11.037
5. Conners EE, Panagiotakopoulos L, Hofmeister MG, et al. Screening and Testing for Hepatitis B Virus Infection: CDC Recommendations - United States, 2023. MMWR Recomm Rep. 2023;72(1):1-25. doi:10.15585/mmwr.rr7201a1
Method Description
Describes how the test is performed and provides a method-specific reference
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 analyzer. Patient's sample is pretreated first with a reducing reagent, and after the addition of synthetic HBc antigen (HBcAg), complexes are formed with HBc antibodies 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 results are determined by comparing the electrochemiluminescence signal generated from the reaction product in the sample to the cutoff index (COI) value set from assay reagent lot-specific assay calibration.(Package insert: Elecsys Anti-HBc II. Roche Diagnostics; v1.0, 04/2022)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
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.
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
Indicates the location of the laboratory that performs the test
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 account representative. 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.
CPT codes are provided by the performing laboratory.
86704
G0499 (if appropriate)
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| HBCSN | HBc Total Ab Scrn, S | 13952-7 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| HBCSN | HBc Total Ab Scrn, S | 13952-7 |