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Test ID: HBNTP Hepatitis B Surface Antigen Confirmation, Prenatal, Serum

Reporting Name

HBs Ag Confirmation Prenatal, S

Useful For

Diagnosis of acute, recent, or chronic hepatitis B infection in prenatal patients

 

This test is not useful during the "window period" of acute hepatitis B virus (HBV) infection (ie, after disappearance of HBsAg and prior to appearance of hepatitis B surface antibody).

 

This test is not suitable as stand-alone prenatal screening test of HBsAg status in pregnant women.

 

This test is not offered as a HBsAg screening or confirmatory test for blood donor specimens.

Clinical Information

Hepatitis B virus (HBV) is endemic throughout the world. The infection is spread primarily through percutaneous contact with infected blood products (eg, blood transfusion, sharing of needles by intravenous drug addicts). The virus is also found in various human body fluids, and it is known to be spread through oral and genital contact. HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions, but it is not commonly transmitted transplacentally.

 

Hepatitis B surface antigen (HBsAg) is the first serologic marker appearing in the serum at 6 to 16 weeks following exposure to HBV. In acute infection, HBsAg usually disappears in 1 to 2 months after the onset of symptoms. Persistence of HBsAg for more than 6 months in duration indicates development of either a chronic carrier state or chronic HBV infection.

 

For information, see the following:

-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

-HBV Infection-Monitoring Before and After Liver Transplantation

-Viral Hepatitis Serologic Profiles

Interpretation

A reactive screen result (signal-to-cutoff ratio ≥1.00 but ≤100.0) confirmed as positive by a hepatitis B surface antigen (HBsAg) confirmatory test is indicative of acute or chronic hepatitis B virus (HBV) infection or chronic HBV carrier state.

 

Specimens with reactive screen results but negative (ie, not confirmed) HBsAg confirmatory test results are likely to contain cross-reactive antibodies from other infectious or immunologic disorders. Repeat testing at a later date is recommended if clinically indicated.

 

Confirmed presence of HBsAg is frequently associated with HBV replication and infectivity, especially when accompanied by presence of hepatitis B envelope (HBe) antigen and/or detectable HBV DNA.

 

For more information, see the following:

-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

-HBV Infection-Monitoring Before and After Liver Transplantation

-Viral Hepatitis Serologic Profiles

Report Available

2 to 4 days

Day(s) Performed

Monday, Wednesday, Friday

Clinical Reference

1. Bonino F, Piratvisuth T, Brunetto MR, Liaw YF: Diagnostic markers of chronic hepatitis B infection and disease. Antiviral Therapy. 2010;15(3):35-44. doi: 10.3851/IMP1622

2. 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

3. 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

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 9, 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 9, 2022. Available at www.cdc.gov/hepatitis/hbv/testingchronic.htm

Method Name

Only orderable as a reflex. For more information see HBAGP / Hepatitis B Surface Antigen Prenatal, Serum.

 

Chemiluminescence Immunoassay (CIA)

Specimen Type

Serum SST


Ordering Guidance


Postmortem, cadaver, and hemolyzed serum specimens should be tested only by assays that are US Food and Drug Administration-licensed for testing on such specimen sources. Order HBGCD / Hepatitis B Surface Antigen for Cadaveric or Hemolyzed Specimens, Serum.

 

Testing for acute HBV infection should also include HBIM / Hepatitis B Core Antibody, IgM, Serum.



Specimen Required


Only orderable as a reflex. For more information see HBAGP / Hepatitis B Surface Antigen Prenatal, Serum.

 

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 2 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.


Specimen Minimum Volume

1.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 28 days
  Refrigerated  7 days
  Ambient  24 hours

Reference Values

Only orderable as a reflex. For more information see HBAGP / Hepatitis B Surface Antigen Prenatal, Serum.

 

Negative

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

87341

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HBNTP HBs Ag Confirmation Prenatal, S 7905-3

 

Result ID Test Result Name Result LOINC Value
HBNTP HBs Ag Confirmation Prenatal, S 7905-3
Mayo Clinic Laboratories | Microbiology and Infectious Disease Catalog Additional Information:

mml-hepatitis