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HelpTest Code EAG Hepatitis B Virus e Antigen, Serum
Reporting Name
Hepatitis Be Ag, SUseful For
Determining the presence or absence of detectable hepatitis B virus e antigen in monitoring infection status of individuals with chronic hepatitis B
Determining infectivity of hepatitis B virus (HBV) carriers
Monitoring serologic response of chronically HBV-infected patients receiving antiviral therapy
Testing Algorithm
For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
Serum SSTOrdering Guidance
If ordered with HBVQN / Hepatitis B Virus (HBV) DNA Detection and Quantification by Real-Time PCR, Serum; send separate vials.
Additional Testing Requirements
Necessary Information
Date of collection is required.
Specimen Required
Patient Preparation: For 24 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).
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: 0.7 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 plastic vial.
Specimen Minimum Volume
0.6 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum SST | Frozen (preferred) | 90 days | |
| Refrigerated | 6 days | ||
| Ambient | 72 hours |
Special Instructions
Day(s) Performed
Monday through Saturday
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
87350
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| EAG | Hepatitis Be Ag, S | 13954-3 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| EAG | Hepatitis Be Ag, S | 13954-3 |
Clinical Information
Hepatitis B virus e antigen (HBeAg) is found in the early phase of hepatitis B infection soon after hepatitis B virus surface antigen becomes detectable. Serum levels of both antigens rise rapidly during the period of viral replication. The presence of HBeAg correlates with hepatitis B virus (HBV) infectivity, the number of infectious virions, and the presence of HBV core antigen in the infected hepatocytes.
In HBV carriers and patients with chronic hepatitis B, positive HBeAg results usually indicate presence of active HBV replication and high infectivity. A negative HBeAg result indicates very minimal or no HBV replication.
For more information, see the following:
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Cautions
This assay has not been licensed by the US Food and Drug Administration for testing cord blood specimens or screening donors of blood, plasma, human cell, or tissue products.
For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination, and other findings.
Specimens should not be taken from patients receiving therapy with high biotin doses (ie, >5 mg/day) until at least 8 hours following the last biotin administration.
Drug interference studies were performed in vitro and may not assess the potential interferences that might be seen after the drugs are metabolized in vivo.
A reactive hepatitis B virus e antigen (HBeAg) result does not exclude co-infection by another hepatitis virus. False positive results due to non-specific reactivity cannot be ruled out with the Elecsys HBeAg assay. In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.
Disappearance of HBe antigen or appearance of HBe antibody in serum does not completely rule-out chronic hepatitis B carrier state or infectivity.
A non-reactive test result does not exclude the possibility of exposure to hepatitis B virus. Negative HBeAg results may occur during early infection due to delayed seroconversion. False negative results may occur due to antigen levels below the detection limit of this assay or if the patient’s antigen does not react with the antibody used in this test.
Results obtained with the Elecsys HBeAg assay may not be used interchangeably with values obtained with different manufacturers’ assay methods.
Performance characteristics of this assay have not been established in pregnant women, or in populations of immunocompromised or immunosuppressed patients.
Assay performance characteristics have not been stablished for the following specimen characteristics or specimen types:
-Grossly icteric (total bilirubin level >40 mg/dL)
-Grossly lipemic (intralipid level >2200 mg/dL)
-Grossly hemolyzed (hemoglobin level >2200 mg/dL)
-Specimen containing particulate matter
-Heat-inactivated specimens
-Specimens stabilized with azide
-Specimen types other than serum
Report Available
1 to 3 daysSpecimen Retention Time
14 daysReject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
| Heat-inactivated specimen | Reject |
Method Name
Electrochemiluminescence Immunoassay (ECLIA)
Forms
If not ordering electronically, complete, print, and send 1 of the following: