Test Catalog

Test Id : HBVPE

Hepatitis B Virus Past Exposure Panel, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Screening for past exposure to hepatitis B virus (HBV)

 

Determining HBV infection status prior to initiating chemotherapy or other immunosuppressive therapies

Highlights

This test panel is intended to screen for presence of past or active hepatitis B virus infection in individuals who will be receiving chemotherapy, immunosuppressive therapy, or organ transplantation.

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If hepatitis B surface antigen (HBsAg) is reactive, then HBsAg confirmation will be performed at an additional charge.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Chemiluminescence Immunoassay (CIA) 

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Hepatitis B Past Exposure, S

Aliases
Lists additional common names for a test, as an aid in searching

HBVPE

Hepatitis Profile

Hepatitis B Screen

Past Exposure Hep B

Hepatitis B

Chronic Hepatitis B

HBV

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If hepatitis B surface antigen (HBsAg) is reactive, then HBsAg confirmation will be performed at an additional charge.

Specimen Type
Describes the specimen type validated for testing

Serum SST

Necessary Information

Date of collection is required.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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. 

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

1 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 28 days
Refrigerated 7 days
Ambient 24 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

Screening for past exposure to hepatitis B virus (HBV)

 

Determining HBV infection status prior to initiating chemotherapy or other immunosuppressive therapies

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If hepatitis B surface antigen (HBsAg) is reactive, then HBsAg confirmation will be performed at an additional charge.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Hepatitis B is a DNA viral infection that is endemic throughout the world. The hepatitis B virus (HBV) is transmitted parenterally or percutaneously from exposure to contaminated blood, blood products, or injection needles, sexually from exposure to body fluids from infected individuals, or perinatally from mother to child during birth delivery by contact with infected mother's blood and vaginal secretions. Transplacental transmission from mother to fetus is uncommon.

 

HBV persists and causes chronic infection (defined as being positive for hepatitis B virus surface antigen: HBsAg in serum or plasma for minimum 6 months) in about 10% of individuals who had acute infection during childhood. These individuals may become asymptomatic HBV carriers (ie, inactive chronic hepatitis B), while others may develop chronic liver diseases including cirrhosis and hepatocellular carcinoma. Asymptomatic HBV carriers are at risk (up to 50%) for decompensation of liver function with acute HBV replication (ie, HBV reactivation) during immunosuppression from chemotherapy, immunosuppressive therapy, or organ transplantation.

 

Individuals who recovered from acute hepatitis B (defined as being negative for HBsAg, positive for total HBV core antibodies, negative or positive for HBV virus surface antibody) are lower risk (up to 20%) of HBV reactivation than those with inactive chronic hepatitis B during immunosuppressive therapy or organ transplantation.

 

For individuals born in regions of the world where HBV prevalence is moderate to high, universal HBV serologic screening before initiation of immunosuppressive therapy is recommended. In the absence of systematic, risk-based testing, universal HBV serologic screening is an option to reduce the risk of missing persons with HBV infection prior to initiation of immunosuppressive treatment.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

See Viral Hepatitis Serologic Profiles in Special Instructions.

Interpretation
Provides information to assist in interpretation of the test results

Hepatitis B virus surface antigen (HBsAg) is the first serologic marker appearing in blood 6 to 16 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 virus surface 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 CDC guidance, individuals with HBsAb levels of 10 mIU/mL or greater after completing an HBV vaccination series are considered protected from hepatitis B.

 

Negative HBsAb results (levels of < 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 virus 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 Ab result is indicative of recovery from HBV infection. A positive HBsAb result with a negative HBc total Ab result is consistent with immunity to hepatitis B from HBV vaccination.

 

Summary of interpretation of the various HBV serologic test result profiles is provided in the table below:

 

HBV serologic test results

Interpretation

HBsAg

HBc total Ab

HBs Ab

+

+

-

Chronic hepatitis B

-

+

+

Past HBV infection (resolved)

-

+

-

Past HBV infection, resolved or false-positive

-

-

+

Immune (from HBV vaccination)

-

-

-

Uninfected (not immune)

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Schillie S, Vellozzi C, Reingold A, et al: Prevention of hepatitis B virus infection in the United States: Recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2018;67(No. RR-1):1–31. doi: 10.15585/mmwr.rr6701a1

2. Centers for Disease Control and Prevention (CDC), Division of Viral Hepatitis: Interpretation of hepatitis B serologic test results. Accessed January 4, 2021. Available at www.cdc.gov/hepatitis/HBV/PDFs/SerologicChartv8.pdf

3. 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

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

Hepatitis B Surface Antigen Screen:

This immunometric technique involves the simultaneous reaction of hepatitis B surface antigen (HBsAg) in the sample with mouse monoclonal anti-hepatitis B surface (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 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 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, version 13.1. Ortho-Clinical Diagnostics, Inc; 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 nonneutralizing 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 nonneutralized control sample.(Package insert: VITROS HBsAg Confirmation assay. No GEM4201, version 13.1. Ortho-Clinical Diagnostics, Inc;09/06/2019)

 

Hepatitis B Surface Antibody:

This chemiluminescent immunoassay is based on an immunometric technique in which the anti-HBs present in the clinical serum sample reacts with HBsAg (ad and ay subtypes) coated onto the assay reaction wells. A 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 is 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, version 14.0. Ortho-Clinical Diagnostics, Inc;04/08/2020)

 

Hepatitis B core Total Antibodies:

The VITROS anti-hepatitis B core (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, version 13.1. Ortho-Clinical Diagnostics, Inc;09/06/2019)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86706

86704

87340

87341 (if appropriate)

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports