Diagnosis and evaluation of patients at risk for or suspected of having chronic hepatitis B
This test is not offered as a screening or confirmatory test for blood donor specimens.
This test is not useful during the "window period" of acute hepatitis B virus infection (ie, after disappearance of hepatitis B surface antigen [HBsAg] and prior to appearance of hepatitis B surface antibody).
This test is not useful as a stand-alone prenatal screening test of HBsAg status in pregnant women.
Test Id | Reporting Name | Available Separately | Always Performed |
---|---|---|---|
HBGSN | HBs Antigen Scrn, S | Yes | Yes |
Test Id | Reporting Name | Available Separately | Always Performed |
---|---|---|---|
EAG | Hepatitis Be Ag, S | Yes | No |
HBGSC | HBs Antigen Screen Confirmation, S | No | No |
HEAB | HBe Antibody, S | Yes | No |
If hepatitis B surface antigen (HBsAg) is reactive, then HBsAg confirmation will be performed at an additional charge. If HBsAg confirmation is positive, then hepatitis B e antigen (HBeAg) and hepatitis B e antibody (anti-HBe) tests will be performed at an additional charge.
The following algorithms are available:
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
-HBV Infection-Monitoring Before and After Liver Transplantation
Chemiluminescence Immunoassay (CIA)
CHSBM
CHBVS
HBV
Hepatitis Screen
If hepatitis B surface antigen (HBsAg) is reactive, then HBsAg confirmation will be performed at an additional charge. If HBsAg confirmation is positive, then hepatitis B e antigen (HBeAg) and hepatitis B e antibody (anti-HBe) tests will be performed at an additional charge.
The following algorithms are available:
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
-HBV Infection-Monitoring Before and After Liver Transplantation
Serum SST
Date of collection is required.
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.
Supplies: Sarstedt 5 mL Aliquot Tube (T914)
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 plastic vial.
If not ordering electronically, complete, print, and send 1 of the following:
1.5 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 |
Diagnosis and evaluation of patients at risk for or suspected of having chronic hepatitis B
This test is not offered as a screening or confirmatory test for blood donor specimens.
This test is not useful during the "window period" of acute hepatitis B virus infection (ie, after disappearance of hepatitis B surface antigen [HBsAg] and prior to appearance of hepatitis B surface antibody).
This test is not useful as a stand-alone prenatal screening test of HBsAg status in pregnant women.
If hepatitis B surface antigen (HBsAg) is reactive, then HBsAg confirmation will be performed at an additional charge. If HBsAg confirmation is positive, then hepatitis B e antigen (HBeAg) and hepatitis B e antibody (anti-HBe) tests will be performed at an additional charge.
The following algorithms are available:
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
-HBV Infection-Monitoring Before and After Liver Transplantation
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 contact. HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions, but it is not commonly transmitted transplacentally.
Hepatitis B surface antigen (HBsAg) is the first serologic marker appearing in the serum at 6 to 16 weeks following exposure to HBV. In acute infection, HBsAg usually disappears in 1 to 2 months after the onset of symptoms. Persistence of HBsAg for more than 6 months in duration indicates development of either a chronic carrier state or chronic HBV infection.
The following algorithms are available:
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
-HBV Infection-Monitoring Before and After Liver Transplantation
Negative
A reactive screen result (signal to cutoff ratio; S/Co ratio > or =1.0 but < or =100.0) confirmed as positive by hepatitis B surface antigen (HBsAg) confirmatory test (see Method Description) or a positive screen result (S/Co ratio >100.0) is indicative of acute or chronic hepatitis B virus (HBV) infection, or chronic HBV carrier state.
Specimens with reactive screen results but negative (ie, not confirmed) HBsAg confirmatory test results are likely to contain cross-reactive antibodies from other infectious or immunologic disorders. 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 e-antigen or detectable HBV DNA.
The following algorithms are available:
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
-HBV Infection-Monitoring Before and After Liver Transplantation
Positive hepatitis B surface antigen (HBsAg) screen results (ie, signal-to-cutoff ratio >100.0) without need for confirmation testing should be interpreted in conjunction with test results of other hepatitis B virus (HBV) serologic markers (eg, hepatitis B surface antibody, hepatitis B core antibody [anti-HBc] total, and anti-HBc IgM).
Positive HBsAg test results should be reported by the health care provider to the State Department of Health, as required by law in some states.
Individuals, especially neonates and children, who recently received hepatitis B vaccination may have transient positive HBsAg test results because of the large dose of HBsAg used in the vaccine relative to the individual's body mass.
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 specimens
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. Servoss JC, Friedman LS: Serologic and molecular diagnosis of hepatitis B virus. Clin Liver Dis. 2004 May;8(2):267-281. doi: 10.1016/j.cld.2004.02.001
3. Badur S, Akgun A: Diagnosis of hepatitis B infections and monitoring of treatment. J Clin Virol. 2001 Jun;21(3):229-237. doi: 10.1016/s1386-6532(01)00147-0
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 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. 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: 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
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) > or =1.0 but < or =100.0 will be confirmed by the VITROS HBsAg Confirmatory assay. Specimens that are strongly positive (ie, S/Co ratio >100.0) do not require this confirmation.
HBsAg:
This immunometric technique involves the simultaneous reaction of HBsAg in the sample with mouse monoclonal HBs antibody (anti-HBs) coated onto the wells and a horseradish peroxidase (HRP)-labeled mouse monoclonal anti-HBs 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 is 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 VITROS Immunodiagnostic System. The amount of HRP conjugate bound is indicative of the level of HBsAg present in the sample.(Package insert: VITROS HBsAg assay, GEM1201, version 13.1. Ortho-Clinical Diagnostics, Inc; 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, version 13.1. Ortho-Clinical Diagnostics, Inc; 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.
87340
G0499-(if appropriate)
Test Id | Test Order Name | Order LOINC Value |
---|---|---|
CHBVS | Chronic Hept Scrn B, S | 5196-1 |
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.
|
---|---|---|
HBAGS | HBs Antigen Scrn, S | 5196-1 |
Change Type | Effective Date |
---|---|
New Test | 2022-01-25 |