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Test ID: HBAGP Hepatitis B Surface Antigen Prenatal, Serum

Reporting Name

HBs Antigen Prenatal, S

Useful For

Screening pregnant women for evidence of chronic hepatitis B virus (HBV) (or hepatitis B carrier state) to identify neonates who are at high risk of acquiring HBV at birth

 

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

 

This test is not useful for diagnosis of hepatitis B during the “window period” of acute HBV infection (ie, after disappearance of hepatitis B surface antigen and prior to appearance of hepatitis B surface antibody).

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 contacts. HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions, but it is not commonly transmitted transplacentally.

 

Infection of the infant can occur if the mother is a chronic hepatitis B surface antigen carrier or has an acute HBV infection at the time of delivery. Transmission is rare if an acute infection occurs in either the first or second trimester of pregnancy.

Interpretation

A reactive screen result confirmed as positive by 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 initially reactive test results but negative (not confirmed) by HBsAg confirmatory test results are likely to contain cross-reactive antibodies from other infectious or immunologic disorders. These unconfirmed HBsAg-reactive screening test results should be interpreted in conjunction with test results of other HBV serologic markers (eg, hepatitis B surface antibody; hepatitis B core antibody, total and IgM). 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 the presence of hepatitis B envelope antigen (HBe) and/or detectable HBV DNA.

Report Available

Same day/1 to 2 days

Day(s) Performed

Monday through Sunday

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;21:229-237. 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;8:267-281. 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;161:58-66. 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;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;156:355-368. 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 July 8, 2021. 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 October 8, 2019. Accessed April 8, 2020. Available at: www.cdc.gov/hepatitis/hbv/testingchronic.htm

Method Name

Chemiluminescence Immunoassay (CIA)

Specimen Type

Serum SST


Ordering Guidance


This test should not be used to test symptomatic individuals who may or may not have risk factors for hepatitis B virus (HBV) infection. For testing such individuals, order HBAG / Hepatitis B Surface Antigen, 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 HBGSN / Hepatitis B Surface Antigen Screen, Serum.

 

This test is not intended for testing cadaver or grossly hemolyzed specimens. For testing such patients, order HBGCD / Hepatitis B Surface Antigen for Cadaveric or Hemolyzed Specimens, Serum, which is FDA-approved for testing on these sources.



Additional Testing Requirements


Testing for acute hepatitis B virus (HBV) infection should also include HBIM / Hepatitis B Core Antibody, IgM, Serum, as during the acute HBV infection "window period," hepatitis B surface (HBs) antigen and HBs antibody may not be detected.



Necessary Information


1. Date of collection is required.

2. Indicate if specimens are from autopsy/cadaver or hemolyzed sources so that the proper FDA-licensed assay can be performed.



Specimen Required


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

0.6 mL

Specimen Stability Information

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

Reference Values

Negative

See Viral Hepatitis Serologic Profiles in Special Instructions.

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

87340

87341 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HBAGP HBs Antigen Prenatal, S 5196-1

 

Result ID Test Result Name Result LOINC Value
HBSAP HBs Antigen Prenatal, S 5196-1

Testing Algorithm

If hepatitis B surface antigen (HBsAg) prenatal is reactive, then HBsAg confirmation will be performed at an additional charge.

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HBNTP HBs Ag Confirmation Prenatal, S No No

Special Instructions

Forms

If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen. 

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

mml-hepatitis