Test ID: HBCPR Hepatitis B Core Total Antibodies Prenatal, Serum
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 Core Total Antibodies, Serum.
This test should not be used to screen or test asymptomatic, nonpregnant individuals with or without risk factors for HBV infection. For testing such patients, order HBCSN / Hepatitis B Core Total Antibodies Screen, Serum.
If hepatitis B core total antibody test that reflexes to hepatitis B core IgM, order CORAB / Hepatitis B Core Total Antibodies, with Reflex to Hepatitis B Core Antibody IgM, Serum.
Necessary Information
Date of collection is required.
Specimen Required
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.
Useful For
Diagnosis of recent or past hepatitis B infection in pregnant individuals
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 among 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.
Testing Algorithm
For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management.
Special Instructions
Method Name
Chemiluminescence Immunoassay (CIA)
Reporting Name
HBc Total Ab Prenatal, SSpecimen Type
Serum SSTSpecimen Minimum Volume
0.4 mL
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Serum SST | Frozen (preferred) | 28 days | |
Refrigerated | 7 days | ||
Ambient | 24 hours |
Clinical Information
Hepatitis B core antibodies (anti-HBc) appear shortly after the onset of symptoms of hepatitis B infection and soon after the appearance of HB surface antigen (HBsAg). Initially, anti-HBc consist almost entirely of the IgM class, followed by appearance of anti-HBc IgG, for which there is no commercial diagnostic assay.
The HBc total antibodies 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 HBs antigen. HBc total antibodies may be the only serologic marker remaining years after exposure to hepatitis B.
This assay is U S Food and Drug Administration approved for in vitro diagnostic use and not for screening cell, tissue, and blood donors.
Reference Values
Negative
Interpretation depends on clinical setting.
For more information, see Viral Hepatitis Serologic Profiles.
Interpretation
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 anti-HBc 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 1 month is also recommended for these neonatal patients.
Clinical Reference
1. Bonino F, Piratvisuth T, Brunetto MR, Liaw YF: Diagnostic markers of chronic hepatitis B infection and disease. Antivir Ther. 2010;15(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. WHO Guidelines Development Group: WHO 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
Day(s) Performed
Monday through Saturday
Report Available
1 to 3 daysTest 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
86704
LOINC Code Information
Test ID | Test Order Name | Order LOINC Value |
---|---|---|
HBCPR | HBc Total Ab Prenatal, S | 13952-7 |
Result ID | Test Result Name | Result LOINC Value |
---|---|---|
HBCPR | HBc Total Ab Prenatal, S | 13952-7 |
Forms
If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.
mml-hepatitis