Evaluating and monitoring individuals with known chronic hepatitis B
Monitoring hepatitis B viral infectivity after resolution of acute hepatitis B
| Test Id | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HBAG | HBs Antigen, S | Yes | Yes |
| EAG | Hepatitis Be Ag, S | Yes | Yes |
| HEAB | HBe Antibody, S | Yes | Yes |
| Test Id | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HBGNT | HBs Antigen Confirmation, S | No | No |
If the hepatitis B surface antigen (HBsAg) result is reactive, then HBsAg confirmation will be performed at an additional charge.
For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Electrochemiluminescence Immunoassay (ECLIA)
Hepatitis Screen
HBV (Hepatitis B Virus)
CHSBP
If the hepatitis B surface antigen (HBsAg) result is reactive, then HBsAg confirmation will be performed at an additional charge.
For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Serum SST
1. Date of collection is required.
2. Indicate "Type B"
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
Submission Container/Tube: Plastic vial
Specimen Volume: 1.2 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. Transfer serum into a plastic vial.
If not ordering electronically, complete, print, and send 1 of the following:
0.9 mL
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum SST | Frozen (preferred) | 90 days | |
| Refrigerated | 6 days | ||
| Ambient | 72 hours |
Evaluating and monitoring individuals with known chronic hepatitis B
Monitoring hepatitis B viral infectivity after resolution of acute hepatitis B
If the hepatitis B surface antigen (HBsAg) result is reactive, then HBsAg confirmation will be performed at an additional charge.
For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Hepatitis B virus (HBV) is a DNA virus that is endemic throughout the world. The infection is spread primarily through percutaneous contact with infected blood products (eg, blood transfusion and sharing of needles among injection drug users) and body fluids (eg, sexual contact). The virus is found in virtually every type of human body fluid and 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; it is not commonly transmitted transplacentally.
After a course of acute illness, HBV persists in approximately 10% of exposed individuals (ie, chronic hepatitis B). Some of these carriers or chronically infected individuals remain asymptomatic, while others develop chronic liver disease, including cirrhosis and hepatocellular carcinoma.
Serum levels of both hepatitis B e antigen (HBeAg) and hepatitis B surface antigen rise rapidly during the period of viral replication. The presence of HBeAg in serum correlates with viral infectivity, the number of infectious virions, and the presence of HBV core antigen in the infected hepatocytes.
During recovery from acute hepatitis B, HBeAg level declines and becomes undetectable in the serum, while HBe antibody (anti-HBe) appears and becomes detectable in the serum. Anti-HBe usually remains detectable for many years after recovery from acute HBV infection.
In HBV carriers and patients with chronic hepatitis B, positive HBeAg results usually indicate presence of active HBV replication and high infectivity, while a negative HBeAg result indicates very minimal or no HBV replication. Positive anti-HBe results usually indicate inactivity of the virus and low infectivity, and such positive results in the presence of detectable HBV DNA in serum also indicate active viral replication in these patients.
HEPATITIS B SURFACE ANTIGEN:
Negative
HEPATITIS Be ANTIGEN:
Negative
HEPATITIS Be ANTIBODY:
Negative
Interpretation depends on clinical setting. See Viral Hepatitis Serologic Profiles.
Hepatitis B surface antigen (HBsAg) is the first serologic marker appearing in the serum 6 to 8 weeks following hepatitis B virus (HBV) infection. In acute cases, HBsAg usually disappears 1 to 2 months after the onset of symptoms. Persistence of HBsAg for more than 6 months indicates development of either chronic carrier state or chronic liver disease.
HBs antibody appears with the resolution of acute hepatitis B after the disappearance of HBsAg. Anti-HBs also appears as the immune response following a course of inoculation with the hepatitis B vaccine.
Hepatitis B core (HBc) IgM and total antibodies appears shortly after the onset of symptoms of HBV infection, and HBc total antibodies may be the only serologic marker remaining years after exposure to hepatitis B.
The presence of hepatitis B e antigen correlates with infectivity, the number of viral Dane particles, the presence of core antigen in the nucleus of the hepatocyte, and the presence of viral DNA polymerase in serum. HBe antibody-positivity in a carrier is often associated with chronic asymptomatic infection.
If the patient has a sudden exacerbation of disease, testing for anti-hepatitis C and anti-hepatitis D virus (HDV) total is recommended.
If HBsAg converts to negative and patient's condition warrants, consider testing for HBs antibody.
If HBsAg is confirmed positive, testing for anti-HDV total is recommended.
For more information see:
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Positive hepatitis B surface antigen (HBsAg) results will need to be reported by the healthcare providers to their communicable disease surveillance units of state department of health, as required by law in various states.
Disappearance of hepatitis B e antigen (HBeAg) or appearance of anti-HBe in serum does not completely rule-out chronic hepatitis B virus carrier state or infectivity.
Serum specimens from individuals taking multivitamins containing biotin or biotin supplements of 20 mg or more per day may have false-negative HBeAg and false-positive HBe antibody results due to interference of biotin with the assay. Such individuals should stop taking these biotin-containing dietary supplements for a minimum of 12 hours before blood collection for this test.
Performance characteristics of these assays have not been established in patients younger than 2 years, pregnant women, or in populations of immunocompromised or immunosuppressed patients. These assays are not licensed by the US Food and Drug Administration for testing cord blood samples or screening donors of blood, plasma, human cell, or tissue products.
Performance characteristics have not been established for the following specimen characteristics:
-Grossly icteric (total bilirubin level of >25 mg/dL)
-Grossly lipemic (Intralipid level of >1500 mg/dL)
-Grossly hemolyzed (hemoglobin level of >1600 mg/dL)
-Containing particulate matter
-Cadaveric specimen
1. LeFevre 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(1):58-66. doi:10.7326/M14-1018
2. 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
3. Coffin CS, Zhou K, Terrault NA. New and old biomarkers for diagnosis and management of chronic hepatitis B virus infection. Gastroenterology. 2019;156(2):355-368. doi:10.1053/j.gastro.2018.11.037
4. WHO guidelines on hepatitis B and C testing. World Health Organization; 2017. Accessed December 19, 2023. Available at www.who.int/publications/i/item/9789241549981
5. Conners EE, Panagiotakopoulos L, Hofmeister MG, et al. Screening and testing for hepatitis B virus infection: CDC recommendations - United States, 2023. MMWR Recomm Rep. 2023;72(1):1-25. doi:10.15585/mmwr.rr7201a1
Hepatitis B Surface Antigen:
The Elecsys HBsAg (hepatitis B surface antigen) II assay is based on the sandwich principle and performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. HBsAg present in the patient's sample reacts with 2 biotinylated monoclonal anti-HBs, and a mixture of monoclonal anti-HBs and polyclonal anti-HBsAg antibodies labeled with a ruthenium complex react to form a sandwich complex. After addition of streptavidin-coated microparticles (solid phase), the complexes bind to the solid phase via interaction of biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then washed away, and voltage is applied to the electrode which induces chemiluminescent emission that is measured by a photomultiplier. Test result is determined by comparing the electrochemiluminescence signal generated from the reaction product in the patient's sample to the cutoff index (COI) value set from reagent lot-specific assay calibration.(Package insert: Elecsys HBsAg II. Roche Diagnostics; v3.0, 02/2022)
HBsAg Confirmation:
The Elecsys HBsAg II Auto Confirm assay is performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. This test is based on 2 parallel measurements. Patient's sample is treated first with the control pretreatment reagent (PT2) prior to immunoreaction. This measurement serves as a reference. For the second measurement the sample is treated with the confirmatory pretreatment reagent (PT1) prior to immunoreaction. During incubation with confirmatory pretreatment, unlabeled polyclonal anti-HBs are bound to the sample HBsAg and thereby block the binding sites for the labeled antibodies used in the following immunoreaction. The confirmation result (%) is automatically assessed by determining the ratio of both measurements.
During testing, the auto-diluted sample is incubated with control pretreatment and confirmatory pretreatment, followed by formation of sandwich complexes of biotinylated monoclonal anti-HBs and a mixture of monoclonal anti-HBs and polyclonal anti-HBs labeled with a ruthenium complex. After addition of streptavidin-coated microparticles (solid phase), the complexes bind to the solid phase via interaction of biotin and streptavidin. The reaction mixture is then aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then washed away, and voltage is applied to the electrode which induces chemiluminescent emission that is measured by a photomultiplier. Result is determined by comparing the electrochemiluminescence signal generated from the reaction product in the patient's samples to the COI value set from reagent lot-specific assay calibration. The confirmation result (%) is calculated from the ratio of the COI obtained for the measurement with confirmatory pretreatment to the COI obtained for the measurement of control pretreatment reaction.(Package insert: Elecsys HBsAg II Auto Confirm. Roche Diagnostics; v1.0, 12/2020)
Hepatitis B Virus e Antigen:
The Elecsys HBeAg (hepatitis B e antigen) assay is based on the sandwich principle and performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. HBeAg present in patient's serum sample reacts with 2 biotinylated monoclonal anti-HBe and a mixture of monoclonal anti-HBe and polyclonal anti-HBe labeled with a ruthenium complex react to form a sandwich complex. After addition of streptavidin-coated microparticles (solid phase), the complexes bind to the solid phase via interaction of biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then washed away, and voltage is applied to the electrode, which induces chemiluminescent emission that is measured by a photomultiplier. Test result is determined by comparing the electrochemiluminescence signal generated from the patient's sample to the COI value set from reagent lot-specific assay calibration.(Package insert: Elecsys HBeAg. Roche Diagnostics; v1.0, 10/2020)
HBe Antibody:
The Elecsys Anti-HBe (hepatitis B e antibody) assay is based on the competitive immunoassay principle and performed using an electrochemiluminescence method on the fully automated cobas e 801 immunochemistry analyzer. Anti-HBe present in the patient's sample first binds to the added synthetic HBeAg. The remaining unbound sites on the synthetic HBeAg become occupied with the added biotinylated antibodies and ruthenium complex-labeled antibodies specific for HBeAg. The entire complex becomes bound to the streptavidin-coated microparticles (solid phase) via interaction of biotin and streptavidin. The reaction mixture is then aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then washed away, and voltage is applied to the electrode, which induces chemiluminescent emission that is measured by a photomultiplier. Test result is determined by comparing the electrochemiluminescence signal generated from the sample to the COI value set from reagent lot-specific assay calibration.(Package insert: Elecsys Anti-HBe. Roche Diagnostics; v1.0, 12/2021)
Monday through Saturday
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.
86707
87340
87350
87341 (if appropriate)
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| CHSBP | Chronic Hepatitis B Profile, S | 95148-3 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| EAG | Hepatitis Be Ag, S | 13954-3 |
| HEAB | HBe Antibody, S | 33463-1 |
| H_BAG | HBs Antigen, S | 5196-1 |