Diagnosis of acute hepatitis B virus (HBV) infection
Identifying acute HBV infection in the serologic window period when hepatitis B surface antigen and anti-hepatitis B surface are negative
Differentiation between acute and chronic or past HBV infections in the presence of positive anti-hepatitis B core
For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management.
Chemiluminescence Immunoassay
Anti-HBc (Immunoglobulin M)
Antibody to Hepatitis Bc
HBV (Hepatitis B Virus)
Hepatitis B Core Ab (Anti-HBc [IgM]), S
Hepatitis B Virus (HBV)
Hepatitis Bc
Hepatitis Bc Antibody (IgM)
Anti-Hepatitis Bc (IgM) (Immunoglobulin M)
HBIM
For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management.
Serum SST
Date of collection is required.
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:
1. Centrifuge blood collection tube per collection tube manufacturer's instructions.
2. Aliquot serum into plastic tube.
If not ordering electronically, complete, print, and send 1 of the following:
0.5 mL
Gross hemolysis | Reject |
Gross lipemia | Reject |
Gross icterus | Reject |
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Serum SST | Frozen (preferred) | 28 days | |
Refrigerated | 7 days | ||
Ambient | 24 hours |
Diagnosis of acute hepatitis B virus (HBV) infection
Identifying acute HBV infection in the serologic window period when hepatitis B surface antigen and anti-hepatitis B surface are negative
Differentiation between acute and chronic or past HBV infections in the presence of positive anti-hepatitis B core
For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management.
Hepatitis B virus (HBV) is a DNA virus that is endemic throughout the world. In the initial (acute) phase of infection, hepatitis B 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 surface antibody (ie, serologic window period).
A positive result indicates recent acute hepatitis B infection.
A negative result suggests lack of recent exposure to the virus in preceding 6 months.
The predictive value of a positive anti-hepatitis B core IgM test result is low when used to test specimens from patients with low prevalence of acute hepatitis B virus infection.
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 specimens
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. Badur S, Akgun A: Diagnosis of hepatitis B infections and monitoring of treatment. J Clin Virol. 2001 Jun;21(3):229-237. doi: 10.1016/s1386-6532(01)00147-0
3. 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
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 1;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. 2018 Aug 22;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 9, 2022. 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 March 28, 2022. Accessed September 9, 2022. Available at www.cdc.gov/hepatitis/hbv/testingchronic.htm
An antibody class capture technique is used. This involves the dilution of the sample and the simultaneous reaction of IgM in the diluted sample with biotinylated mouse monoclonal antihuman-IgM antibody. The immune complex is captured by streptavidin on the wells. Unbound materials are removed by washing. Horseradish peroxidase (HRP)-labeled mouse monoclonal anti-hepatitis B core (anti-HBc) IgM, which has been complexed with recombinant HBc antigen (conjugate), is then captured by anti-HBc specific IgM bound to the wells. Unbound material is removed by washing.
The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminal derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminal 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 bound is indicative of the concentration of anti-HBc IgM present in the sample.(Package insert: VITROS Anti-HBc IgM assay, Pub. No. GEM0216, Version 14.1, Ortho-Clinical Diagnostics; 09/06/2019)
Monday through Saturday
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.
86705
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 |