Test Catalog

Test Id : HBIM

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Hepatitis B Virus Core IgM Antibody, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Diagnosis of acute hepatitis B virus (HBV) infection

 

Identifying acute HBV infection in the serologic window period when hepatitis B virus surface antigen and hepatitis B virus surface antibody results are negative

 

Differentiation between acute, chronic, or past HBV infections in the presence of positive hepatitis B virus core total antibodies

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

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.

Yes

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

HBc IgM Ab, S

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

Anti-HBc (Immunoglobulin M)

Antibody to Hepatitis Bc

HBV (Hepatitis B Virus)

Hepatitis B Virus (HBV)

Hepatitis Bc

Hepatitis Bc Antibody (IgM)

HBIM

Anti-Hepatitis B core (IgM)

Hepatitis B Virus Core Ab (Anti-HBc [IgM]),

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

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, 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: 0.6 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 tube.

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

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
Refrigerated 6 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Diagnosis of acute hepatitis B virus (HBV) infection

 

Identifying acute HBV infection in the serologic window period when hepatitis B virus surface antigen and hepatitis B virus surface antibody results are negative

 

Differentiation between acute, chronic, or past HBV infections in the presence of positive hepatitis B virus core total antibodies

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Hepatitis B virus (HBV) is a DNA virus that is endemic throughout the world. In the initial (acute) phase of infection, hepatitis B virus core antibodies (anti-HBc) consist almost entirely of the IgM antibody class and appear shortly after the onset of symptoms. Anti-HBc IgM can be detected in serum and is usually present for up to 6 months after acute HBV infection. Anti-HBc IgM may be the only serologic marker of a recent hepatitis B infection detectable following the disappearance of hepatitis B surface antigen and prior to the appearance of hepatitis B virus surface antibody (ie, serologic window period).

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

A positive result indicates recent acute hepatitis B infection.

 

A negative result suggests lack of recent exposure to the virus in preceding 6 months.

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-negative hepatitis B core antibody (anti-HBc) IgM 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 IgM antibodies to HBc may not detect all infected individuals. A nonreactive test result does not exclude the possibility of exposure to HBV. In rare cases, interference due to high titers of antibodies to immunological components, streptavidin or ruthenium can occur.

 

The predictive value of a positive HBc IgM antibody test result is low when used to test specimens from patients with low prevalence of acute hepatitis B virus infection.

 

Results obtained with the Elecsys Anti-HBc IgM 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 >2000 mg/dL)

-Containing particulate matter

-Cadaveric specimens

-Specimen types other than serum

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

1. 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;161(1):58-66. doi:10.7326/M14-1018

2. Jackson K, Locarnini S, Gish R. Diagnostics of hepatitis B virus: Standard of care and investigational. Clin Liver Dis. 2018;22:12(1):5-11. doi:10.1002/cld.729

3. 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

4. WHO guidelines on hepatitis B and C testing. Geneva: World Health Organization; February 2017. Accessed December 21, 2023. Available atwww.who.int/hepatitis/publications/HEP17001_WEB11.pdf?ua=1

5. 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 March 28, 2022. Accessed December 21, 2023. Available at www.cdc.gov/hepatitis/hbv/testingchronic.htm

6. 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) IgM assay is based on the sandwich immunoassay principle and performed with an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. Anti-HBc IgM present in patient's sample is pretreated with anti-Fdy reagent to block specific IgG. After addition of biotinylated monoclonal human IgM-specific antibodies, the complexes formed from reaction of ruthenium-labeled HBc antigen, streptavidin-coated microparticles (solid phase), anti-HBc IgM present in the sample, and the biotinylated anti-human IgM bind to the 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, and unbound substances are washed away. Voltage is applied to the electrode that induces chemiluminescent emissions, which are measured by a photomultiplier. Test result is determined by comparing the electrochemiluminescence signal generated from the sample to the cutoff index value set from reagent lot-specific assay calibration.(Package insert: Elecsys Anti-HBc IgM. Roche Diagnostics; v1.0, 09/2020)

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.

Same day/1 to 2 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 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.

86705

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
HBIM HBc IgM Ab, S 24113-3
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.
HBIM HBc IgM Ab, S 24113-3

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

Test Update Resources

Change Type Effective Date
Test Changes - Method 2024-04-18
Test Changes - Method 2024-04-18