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Test Code HBAGP Hepatitis B Virus Surface Antigen Prenatal, Serum

Reporting Name

HBs Antigen Prenatal, S

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Diagnosis of acute, recent, or chronic hepatitis B

 

Determination of chronic hepatitis B status

 

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

 

This test should not be used 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).

Method Name

Electrochemiluminescence Immunoassay (ECLIA)


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 Virus 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 Virus 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 US Food and Drug Administration-approved for testing on these sources.



Additional Testing Requirements


Testing for acute hepatitis B virus (HBV) infection should also include HBIM / Hepatitis B Virus Core IgM Antibody, Serum, as during the acute HBV infection "window period," hepatitis B virus 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 US Food and Drug Administration-licensed assay can be performed.



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Serum gel (red-top tubes are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 0.9 mL

Collection Instructions:

1. Centrifuge blood collection tube per manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot serum into a plastic vial.


Specimen Type

Serum SST

Specimen Minimum Volume

0.7 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 90 days
  Refrigerated  6 days
  Ambient  72 hours

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Reference Values

Negative

See Viral Hepatitis Serologic Profiles.

Interpretation

A reactive screen result (cutoff index value >1.00) confirmed as positive by hepatitis B surface antigen (HBsAg) confirmatory test is indicative of acute or chronic hepatitis B or chronic hepatitis B virus (HBV) carrier state.

 

Specimens with initially reactive test results but negative (not confirmed) by HBsAg confirmatory testing 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, HBs antibody; hepatitis B core [HBc] total antibody, and HBc IgM antibody). If clinically indicated, repeat testing at a later date is recommended.

 

Confirmed presence of HBsAg is frequently associated with HBV replication and infectivity, especially when accompanied by the presence of HBe antigen or detectable HBV DNA.

Day(s) Performed

Monday through Sunday

Report Available

Same day/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

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

Forms

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

-Infectious Disease Serology Test Request (T916)

-Gastroenterology and Hepatology Test Request (T728)

Reflex Tests

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

Testing Algorithm

If the hepatitis B virus surface antigen (HBsAg) result is reactive with cutoff index value greater than 1.00, then HBsAg confirmation testing will be performed at an additional charge.

Special Instructions