Test Id : HBABY

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.

Date of collection is required.

Patient Preparation: For 24 hours before specimen collection, patient should not take multivitamins or dietary supplements containing biotin (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: 1.2 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.

• Viral Hepatitis Serologic Profiles
• Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

If not ordering electronically, complete, print, and send 1 of the following:

-Gastroenterology and Hepatology Test Request (T728)

-Infectious Disease Serology Test Request (T916)

0.9 mL

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. The infection is spread primarily through percutaneous contact with infected blood products (eg, blood transfusion, sharing of needles among injection drug users). The virus is found in virtually every type of human body fluid and is also 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. 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.

After a course of acute illness, HBV persists in about 10% of patients who were infected during adulthood. Some chronic carriers are asymptomatic while others may develop chronic liver disease, including cirrhosis and hepatocellular carcinoma.

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.

Negative

See Viral Hepatitis Serologic Profiles.

Hepatitis B surface antigen (HBsAg) is the first serologic marker appearing in blood 6 to 8 weeks after exposure to hepatitis B virus (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.

Hepatitis B surface antibody (anti-HBs) 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 anti-HBs levels of 11.5 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 anti-HBs levels of 10 mIU/mL or greater after completing an HBV vaccination series are considered protected from hepatitis B infection.(1)

Negative ant-HBs results, defined as anti-HBs levels of less than 8.5 mIU/mL, indicate a lack of recovery from acute or chronic hepatitis B or inadequate immune response to HBV vaccination.

Indeterminate anti-HBs results, defined as anti-HBs levels in the range from 8.5 to less than 11.5 mIU/mL, indicate inability to determine if anti-HBs is present at levels consistent with recovery or immunity. Repeat testing in 1 to 3 months is recommended to determine definitive anti-HBs status.

Hepatitis B virus core (HBc) total and IgM antibodies 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 anti-HBs result along with a positive HBc total antibody result is indicative of recovery from HBV infection. A positive anti-HBs 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

-Viral Hepatitis Serologic Profiles

Assay 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 >1000 mg/dL)

-Grossly hemolyzed (hemoglobin level of >500 mg/dL)

-Contain particulate matter

-Cadaveric specimens

-Heat inactivated specimens

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. Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018;67(4):1560-1599. Available at https://journals.lww.com/hep/fulltext/2018/04000/update_on_prevention,_diagnosis,_and_treatment_of.34.aspx

3. Centers for Disease Control and Prevention: Prevention of hepatitis B virus infection in the United States: Recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2018;67(1):1-31. Available at www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.PDF

4. Centers for Disease Control and Prevention (CDC), Division of Viral Hepatitis: Interpretation of hepatitis B serologic test results. CDC; Accessed December 21, 2023. Available at www.cdc.gov/hepatitis/hbv/interpretationOfHepBSerologicResults.htm

5. Centers for Disease Control and Prevention: Screening and Testing for Hepatitis B Virus Infection: CDC Recommendations-United States, 2023. CDC; Updated August 10, 2023. Accessed December 21, 2023. Available at www.cdc.gov/mmwr/volumes/72/rr/rr7201a1.htm?s_cid=rr7201a1_w

Hepatitis B surface Antibody:

The Elecsys Anti-HBs (hepatitis B surface) quantitative assay is performed using an electrochemiluminescent immunoassay on the automated cobas e 801 immunochemistry analyzer. Anti-HBs present in patient's serum sample reacts with the biotinylated HBsAg (ad and ay subtypes) and HBsAg (ad/ay) labeled with a ruthenium complex to form a sandwich complex. After the addition of streptavidin-coated microparticles, the complexes bind to a solid phase via interaction of biotin and streptavidin.  The reaction mixture is aspirated into the measuring cell where microparticles are magnetically captured onto the surface of the electrode, and unbound substances are washed away. Voltage is applied to the electrode that induces chemiluminescent emissions, which are measured by a photomultiplier. The emission signal generated is directly proportional to the concentration of anti-HBs present in the patient's serum sample.(Package insert: Elecsys Anti-HBs. Roche Diagnostics; v3.0, 03/2024)

Hepatitis B core Total Antibodies:

The Elecsys Anti-HBc (hepatitis B core) II assay is performed using an electrochemiluminescence immunoassay on the automated cobas e 801 analyzer. Hepatitis B viral core antibodies (anti-HBc) present in the patient's sample is pretreated first with a reducing reagent, and after the addition of hepatitis B virus core antigen (HBcAg), complexes are formed with anti-HBc in the sample. The remaining unbound sites on the HBcAg become occupied after addition of biotinylated antibodies and ruthenium complex-labeled antibodies specific for HBcAg, together with streptavidin-coated microparticles. The entire complex becomes bound 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. After unbound substances are washed away, voltage is applied to the electrode that induces chemiluminescent emissions, which are measured by a photomultiplier. Results are determined by comparing the electrochemiluminescence signal generated from the reaction product of the sample to the cutoff index (COI) value set from assay reagent lot-specific assay calibration.(Package insert: Elecsys Anti-HBc II. Roche Diagnostics; v1.0, 04/2022)

Hepatitis B surface Antigen Screen:

The Elecsys HBsAg (hepatitis B surface antigen) II assay is performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analzyer. HBsAg present in the patient's sample reacts with two 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, the complexes become bound 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, and unbound substances are washed away. Voltage is applied to the electrode that induces chemiluminescent emissions, which are measured by a photomultiplier. Test results for each patient's sample are determined by comparing the electrochemiluminescence signal generated from the reaction product to the COI value set from reagent lot-specific assay calibrations.(Package insert: Elecsys HBsAG II. Doc. Roche Diagnostics; v3.0, 02/2022)

Hepatitis B Surface Antigen 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.  For the first measurement, the sample is treated 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-HBsAg antibodies 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-HBsAg antibodies and a mixture of monoclonal anti-HBsAg antibody and polyclonal anti-HBsAg antibodies labeled with a ruthenium complex. After addition of streptavidin-coated microparticles, the complexes become bound 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, and unbound substances are then washed away. Voltage is applied to the electrode that induces chemiluminescent emissions, which are measured by a photomultiplier. Results are determined by comparing the electrochemiluminescence signal generated from the reaction product 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 with control pretreatment.(Package insert: Elecsys HBsAg II Auto Confirm, Doc. 08741034501. Roche Diagnostics; v1.0, 12/2020)

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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)