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Test ID: HBCSN Hepatitis B Core Total Antibodies Screen, 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 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.



Necessary Information


Date of collection is required.



Specimen 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.


Useful For

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.

Method Name

Chemiluminescence Immunoassay (CIA)

Reporting Name

HBc Total Ab Scrn, S

Specimen Type

Serum SST

Specimen 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 (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.

Reference Values

Negative

Interpretation depends on clinical setting.

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 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.

Clinical Reference

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

Day(s) Performed

Monday through Saturday

Report Available

1 to 3 days

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

86704

G0499 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HBCSN HBc Total Ab Scrn, S 13952-7

 

Result ID Test Result Name Result LOINC Value
HBCSN HBc Total Ab Scrn, S 13952-7

Forms

If not ordering electronically, complete, print, and send 1 of the following:

-Gastroenterology and Hepatology Client Test Request (T728)

-Infectious Disease Serology Test Request (T916)

Mayo Clinic Laboratories | Microbiology and Infectious Disease Catalog Additional Information:

mml-hepatitis