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HelpTest Code HBIM Hepatitis B Virus Core IgM Antibody, Serum
Reporting Name
HBc IgM Ab, SUseful For
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
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
Serum SSTNecessary Information
Date of collection is required.
Specimen Required
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.
Specimen Minimum Volume
0.6 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum SST | Frozen (preferred) | 90 days | |
| Refrigerated | 6 days |
Special Instructions
Day(s) Performed
Monday through Saturday
Test Classification
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
86705
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| HBIM | HBc IgM Ab, S | 24113-3 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| HBIM | HBc IgM Ab, S | 24113-3 |
Clinical Information
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).
Interpretation
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
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
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
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)
Report Available
Same day/1 to 2 daysSpecimen Retention Time
14 daysReject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
Method Name
Electrochemiluminescence Immunoassay (ECLIA)
Forms
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Testing Algorithm
For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management.