Determining hepatitis B virus infection and immunity status (with or without perinatal prophylaxis) in infants born to mothers with chronic hepatitis B
This test should be ordered for infants born to mothers with chronic hepatitis B only.
| Test Id | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HBAG | HBs Antigen, S | Yes | Yes |
| HBC | HBc Total Ab, S | Yes | Yes |
| HBAB | HBs 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
Postnatal HBV
HBABY
Hepatitis Profile
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
Date of collection is required.
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 1.5 mL
Collection Instructions:
1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot serum into plastic vial.
If not ordering electronically, complete, print, and send 1 of the following:
1 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 |
Determining hepatitis B virus infection and immunity status (with or without perinatal prophylaxis) in infants born to mothers with chronic hepatitis B
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. After a course of acute illness, HBV persists in about 10% of patients who were infected during adulthood. Some carriers are asymptomatic while others may develop chronic liver disease, including cirrhosis and hepatocellular carcinoma.
HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions; it is not commonly transmitted transplacentally. Infection of the infant can occur if the mother is a chronic hepatitis B surface antigen (HBsAg) carrier or has an acute HBV infection at the time of delivery. Transmission is rare if an acute infection occurs in either the first or second trimester of pregnancy.
Without postexposure prophylaxis (a combination of HBV vaccination and hepatitis B immune globulin), the risk of an infant acquiring HBV from an infected mother as a result of perinatal exposure is 70% to 90% for infants born to mothers who are positive for HBsAg and HBeAg. The risk is 5% to 20% for infants born to HBsAg-positive but HBeAg-negative mothers.
HBV is also spread primarily through percutaneous contact with infected blood products (ie, blood transfusion, sharing of needles by drug users). The virus is found in virtually every type of human body fluid and is also spread through oral and genital contact.
Negative
Hepatitis B surface antigen (HBsAg) is the first serologic marker appearing in blood 6 to 16 weeks after exposure to HBV. A confirmed positive HBsAg result is indicative of acute or chronic hepatitis B. In acute cases, HBsAg usually disappears 1 to 2 months after the onset of symptoms. Persistence of HBsAg for more than 6-months duration indicates development of either a chronic carrier state or chronic hepatitis B.
HBs antibody (HBsAb) appears with the resolution of HBV infection and disappearance of HBsAg. A positive result indicates recovery from acute or chronic hepatitis B or acquired immunity from HBV vaccination. This assay does not differentiate between a vaccine-induced immune response and recovery from HBV infection. Per assay manufacturer's instructions for use, positive results are defined as HBsAb levels of 12.0 mIU/mL or greater, with adequate immunity to hepatitis B after recovery from past infection or HBV vaccination. Per current Centers for Disease Control and Prevention guidance, individuals with HBsAb levels of 10 mIU/mL or greater after completing an HBV vaccination series are considered protected from hepatitis B.(1)
Negative results, defined as HBsAb levels of less than 5.0 mIU/mL, indicate a lack of recovery from acute or chronic hepatitis B or inadequate immune response to HBV vaccination. Indeterminate results, defined as HBsAb levels in the range of 5.0 to 11.9 mIU/mL, indicate inability to determine if HBsAb is present at levels consistent with recovery or immunity. Repeat testing is recommended in 1 to 3 months.
Hepatitis B core (HBc) total antibodies (combined IgG and IgM) appear shortly after the onset of symptoms of HBV infection and may be the only serologic marker remaining years after exposure to HBV. A positive result indicates exposure to HBV infection. A positive HBsAb result along with a positive HBc total antibody result is indicative of recovery from HBV infection. A positive HBsAb result with a negative HBc total antibody result is consistent with immunity to hepatitis B from HBV vaccination.
For more information see:
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Assay 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 >500 mg/dL)
-Contain particulate matter
-Cadaveric specimens
-Heat inactivated specimens
1. Advisory Committee on Immunization Practices; Centers for Disease Control and Prevention (CDC). Immunization of health-care personnel: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011 Nov 25;60(RR-7):1-45
2. Mast EE, Margolis HS, Fiore AE, Advisory Committee on Immunization Practices (ACIP), et al: A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP) part 1: Immunization of infants, children, and adolescents. MMWR Recomm Rep. 2005 Dec 23;54(RR-16):1-31. Erratum in: MMWR Morb Mortal Wkly Rep. 2006 Feb 17;55(6):158-9. Erratum in: MMWR Morb Mortal Wkly Rep. 2007 Dec 7;56(48):1267
3. Centers for Disease Control and Prevention: Interpretation of hepatitis B serologic test results. Accessed October 19, 2022. Available at www.cdc.gov/hepatitis/HBV/PDFs/SerologicChartv8.pdf
4. Bonino F, Piratvisuth T, Brunetto MR, Liaw YF: Diagnostic markers of chronic hepatitis B infection and disease. Antiviral Ther. 2010;15(3):35-44
5. 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
6. Jackson K, Locarnini S, Gish R: Diagnostics of hepatitis B virus: Standard of care and investigational. Clin Liver Dis (Hoboken). 2018 Jul;12(1):5-11. doi: 10.1002/cld.729
7. 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
8. 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
Hepatitis B surface Antibody:
VITROS hepatitis B surface antibody (anti-HBs) assay is performed using an immunometric technique in which the anti-HBs present in the clinical serum sample reacts with hepatitis B surface antigen (HBsAg) (ad and ay subtypes) coated onto the assay reaction wells. A horseradish peroxidase (HRP)-labeled HBsAg conjugate (ad and ay subtypes) then complexes with the bound anti-HBs forming an "antigen sandwich." Unbound materials are 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. HRP in the bound conjugate catalyzes the oxidation of the luminol derivative to produce light. The electron transfer agent increases the level and duration of the light produced. The light signals are detected by the system. The amount of HRP conjugate bound is directly proportional to the concentration of anti-HBs antibody present.(Package insert: VITROS Anti-HBs Quantitative Assay, No GEM1208. Ortho-Clinical Diagnostics, Inc; Version 13.1, 04/08/2020)
Hepatitis B core Total Antibodies:
The VITROS hepatitis B core antibody (anti-HBc) assay is a competitive immunoassay method based on the reaction of anti-HBc in the sample with hepatitis B core antigen (HBcAg)-coated wells. Unbound sample is removed by washing. HRP-labeled antibody conjugate (mouse monoclonal anti-HBc) is then allowed to react with the remaining exposed HBcAg on the well surface. Unbound conjugate is 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 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 concentration of anti-HBc present in the sample.(Package insert: VITROS Anti-HBc Assay, No GEM1211. Ortho-Clinical Diagnostics, Inc; Version 14.1, 09/06/2019)
Hepatitis B surface Antigen Screen:
This immunometric technique involves the simultaneous reaction of HBsAg in the sample with mouse monoclonal anti-HBs coated onto the wells and 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, No GEM1201. Ortho-Clinical Diagnostics, Inc; Version 13.1, 09/06/2019)
Hepatitis B surface Antigen Confirmation:
The VITROS HBsAg confirmatory kit uses the principle of specific antibody neutralization to confirm the presence of HBsAg. The sample is tested twice: the first 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, No GEM4201. Ortho-Clinical Diagnostics, Inc; Version 13.1, 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.
86706
86704
87340
87341 (if appropriate)
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| HBABY | Hepatitis B Perinatal Exposure, S | 77190-7 |
| 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.
|
|---|---|---|
| HBC | HBc Total Ab, S | 13952-7 |
| HB_AB | HBs Antibody, S | 10900-9 |
| HBSQN | HBs Antibody, Quantitative, S | 5193-8 |
| H_BAG | HBs Antigen, S | 5196-1 |