Evaluating patients with confirmed chronic hepatitis B
Monitoring hepatitis B viral infectivity
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 hepatitis B surface antigen (HBsAg) 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
Chemiluminescence Immunoassay (CIA)
Hepatitis Screen
HBV (Hepatitis B Virus)
CHSBP
If hepatitis B surface antigen (HBsAg) 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 do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 3.5 mL
Collection Instructions:
1. Centrifuge per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).
2. Transfer serum into aliquot tube.
If not ordering electronically, complete, print, and send 1 of the following:
2 mL
Gross hemolysis | Reject |
Gross lipemia | Reject |
Gross icterus | Reject |
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Serum SST | Frozen (preferred) | 28 days | |
Refrigerated | 7 days | ||
Ambient | 24 hours |
Evaluating patients with confirmed chronic hepatitis B
Monitoring hepatitis B viral infectivity
If hepatitis B surface antigen (HBsAg) 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 by drug users). 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 patients. Some of these carriers are asymptomatic while others develop chronic liver disease, including cirrhosis and hepatocellular carcinoma.
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 16 weeks following hepatitis B viral (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 (anti-HBs) appears with the resolution of HBV infection 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 antibody (anti-HBc) appears shortly after the onset of symptoms of HBV infection and may be the only serologic marker remaining years after exposure to hepatitis B.
The presence of HBeAg 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. Anti-HBe positivity in a carrier is often associated with chronic asymptomatic infection.
If the patient has a sudden exacerbation of disease, consider ordering anti-HCV and anti-HDV.
If HBsAg converts to negative and patient's condition warrants, consider testing for anti-HBs.
If HBsAg is positive, consider testing for anti-HDV.
The following are available:
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Positive hepatitis B surface antigen (HBsAg) test results should be reported by the attending physician to the State Department of Health, as required by law in some states.
Consider administration of hepatitis B immune globulin and hepatitis B vaccine to individuals exposed to the patient's blood or body fluids.
Performance characteristics of these assays have not been established in patients under the age of 2 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 >20 mg/dL)
-Grossly lipemic (triolein level of >3000 mg/dL)
-Grossly hemolyzed (hemoglobin level of >61 mg/dL)
-Containing particulate matter
-Cadaveric specimen
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
2. Servoss JC, Friedman LS: Serologic and molecular diagnosis of hepatitis B virus. Clin Liver Dis. 2004 May;8(2):267-281
3. Badur S, Akgun A: Diagnosis of hepatitis B infections and monitoring of treatment. J Clin Virol. 2001 Jun;21(3):229-237
4. 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 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 (Hoboken). 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: World Health Organization guidelines on hepatitis B and C testing. World Health Organization; 2017. Accessed October 19, 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. Updated March 28, 2022. Accessed October 19, 2022. Available at www.cdc.gov/hepatitis/hbv/testingchronic.htm
Hepatitis B Surface Antigen:
Specimens are first tested by the VITROS hepatitis B surface antigen (HBsAg) assay. With modification to the assay manufacturer's instructions for use, specimens yielding signal-to-cutoff ratio (S/Co) of1.0 or above but 100.0 or lower will be confirmed by the VITROS HBsAg Confirmatory assay. Specimens that are strongly positive (ie, S/Co >100.0) do not require this confirmation. This immunometric technique involves the simultaneous reaction of HBsAg in the sample with mouse monoclonal anti-hepatitis B surface antibody (anti-HBs) antibody coated onto the wells and a horseradish peroxidase (HRP)-labeled mouse monoclonal anti-HBs antibody in the conjugate. Unbound conjugate is removed by washing. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent are added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The light signals are read by the system. The amount of HRP conjugate bound is indicative of the level of HBsAg present in the sample.(Package insert: VITROS HBsAg assay, GEM1201. Ortho-Clinical Diagnostics, Inc; Version 13.1, 09/06/2019)
HBsAg Confirmation:
The VITROS HBsAg Confirmatory Kit uses the principle of specific antibody neutralization to confirm the presence of HBsAg. The sample is tested twice: one aliquot is incubated with a neutralizing reagent containing high titer anti-HBs (the confirmatory antibody); the second aliquot is incubated with a non-neutralizing control reagent (the sample diluent). The confirmatory antibody binds to HBsAg in the sample inhibiting its reaction in the VITROS HBsAg assay. This leads to a reduced result compared to that for the non-neutralized control sample.(Package insert: VITROS HBsAg Confirmation assay, GEM4201. Ortho-Clinical Diagnostics, Inc; Version 13.1, 09/06/2019)
Hepatitis Be Antigen:
This test is performed using an immunometric technique involving the simultaneous reaction of hepatitis Be antigen (HBeAg) in the sample with biotinylated mouse monoclonal HBeAg antibody and HRP-labeled mouse monoclonal HBeAg antibody in the conjugate. The immune complex is captured by streptavidin on the wells; unbound materials are removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent are added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of HRP conjugate bound is indicative of the level of HBeAg present in the sample.(Package insert: VITROS Immunodiagnostic Product HBeAg Reagent Pack, No. GEM1222. Ortho-Clinical Diagnostics, Inc; Version 9.1, 04/08/2020)
Hepatitis Be Antibody:
This test is performed using a competitive technique which involves preincubation of anti-hepatitis Be antibody (anti-HBe) IgG in the sample with a fixed weight of HBeAg in the assay reagent, followed by incubation with a conjugate reagent that contains biotinylated mouse monoclonal anti-HBe IgG and HRP-labelled mouse monoclonal anti-HBe IgG. The immune complex is captured by streptavidin on the wells. Unbound materials are removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent are added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of HRP conjugate bound is indicative of the level of anti-HBe IgG present in the sample.(Package insert: VITROS Immunodiagnostic Product Anti-HBe Reagent Pack, No. GEM1223. Ortho-Clinical Diagnostics, Inc; Version 9.1, 09/06/2019)
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 Profile (Type B) | 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 |