Diagnosis of recent or past hepatitis B infection
Determination of occult hepatitis B infection in otherwise healthy hepatitis B virus carriers with negative test results for hepatitis B surface antigen, anti-hepatitis B surface, anti-hepatitis B core IgM, hepatitis Be antigen, and anti-HBe
This assay is not useful for differentiating between acute, chronic, and past or resolved hepatitis B infection.
This test should not be used as a screening or confirmatory test for blood donor specimens.
This test should be used to screen or test asymptomatic, nonpregnant individuals with or without risk factors for hepatitis B virus infection.
Chemiluminescence Immunoassay (CIA)
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
Serum SST
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 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 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 Core Total Antibodies, with Reflex to Hepatitis B Core Antibody IgM, Serum.
Date of collection is required.
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
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 (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot serum into plastic vial.
If not ordering electronically, complete, print, and send 1 of the following:
0.4 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 recent or past hepatitis B infection
Determination of occult hepatitis B infection in otherwise healthy hepatitis B virus carriers with negative test results for hepatitis B surface antigen, anti-hepatitis B surface, anti-hepatitis B core IgM, hepatitis Be antigen, and anti-HBe
This assay is not useful for differentiating between acute, chronic, and past or resolved hepatitis B infection.
This test should not be used as a screening or confirmatory test for blood donor specimens.
Hepatitis B core (HBc) antibodies (Ab) appear shortly after the onset of symptoms of hepatitis B infection and soon after the appearance of HB surface antigen (HBsAg). Initially, HBcAb consist almost entirely of the IgM class, followed by the appearance of anti-HBc IgG, for which there is no commercial diagnostic assay.
The HBc total Ab test, which detects both IgM and IgG antibodies, and the test for HBc IgM antibodies may be the only markers of a recent hepatitis B infection detectable in the "window period." The window period begins with the clearance of HBsAg and ends with the appearance of antibodies to HBsAg. HBc total Ab may be the only serologic marker remaining years after exposure to hepatitis B.
This assay is US Food and Drug Administration-approved for in vitro diagnostic use and not for screening cell, tissue, and blood donors.
Negative hepatitis B core (HBc) total antibody (Ab)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.
An inconclusive result suggests the presence of an interfering substance in the patient's serum specimen.
Positive HBc total Ab 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 HBIM / Hepatitis B Core Antibody, IgM, Serum is necessary to confirm an acute or recent infection.
Neonatal patients (<1 month old) with positive HBc total Ab results from this assay should be tested for HBcAb IgM (HBIM / Hepatitis B Core Antibody, IgM, Serum) to rule out possible maternal HBcAb causing false-positive results. Repeat testing using this assay for HBc total Ab within one month is also recommended for these neonatal patients.
Samples containing sodium azide may cause false positive results and should not be tested.
Lipemic and precipitated samples may give inconsistent results.
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
-Heat inactivated 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 July;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;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. Gastroenterol. 2019 Jan;156(2):355-368. doi: 10.1053/j.gastro.2018.11.037
7. WHO Guidelines Development Group: World Health Organization: Guidelines on hepatitis B and C testing. World Health Organization; 2017. Accessed September 28, 2022. Available at www.who.int/publications/i/item/9789241549981
8. Centers for Disease Control and Prevention. Testing and public health management of persons with chronic hepatitis B virus infection. CDC: Updated March 28, 2022. Accessed September 28, 2022. Available at www.cdc.gov/hepatitis/hbv/testingchronic.htm
The VITROS anti-hepatitis B core (anti-HBc) assay is a competitive immunoassay method based on the reaction of anti-HBc in the sample with HBc 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 bound is indicative of the concentration of anti-HBc present in the sample.(Package insert: VITROS Anti-HBc Assay, Pub. No. GEM1211. Ortho-Clinical Diagnostics, Inc; version 13.1, 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.
86704
G0499 (if appropriate)
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 |