Test Catalog

Test Id : CHSBP

Chronic Hepatitis Profile (Type B), Serum

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

Evaluating patients with confirmed chronic hepatitis B

 

Monitoring hepatitis B viral infectivity

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
EAG Hepatitis Be Ag, S Yes Yes
HEAB HBe Antibody, S Yes Yes

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
HBGNT HBs Antigen Confirmation, S No No

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.

 

For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

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

Chronic Hepatitis Profile (Type B)

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

Hepatitis Screen

HBV (Hepatitis B Virus)

CHSBP

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.

 

For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

Specimen Type
Describes the specimen type validated for testing

Serum SST

Necessary Information

1. Date of collection is required.

2. Indicate "Type B"

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

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.

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

Forms

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

-Gastroenterology and Hepatology Client Test Request (T728)

-Infectious Disease Serology Test Request (T916)

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

2 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

Evaluating patients with confirmed chronic hepatitis B

 

Monitoring hepatitis B viral infectivity

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.

 

For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

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

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 addicts). The virus is also 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; others develop chronic liver disease including cirrhosis and hepatocellular carcinoma.

 

The following are available:

-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

-Viral Hepatitis Serologic Profiles

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.

HEPATITIS B SURFACE ANTIGEN:

Negative

 

HEPATITIS Be ANTIGEN:

Negative

 

HEPATITIS Be ANTIBODY:
Negative

 

Interpretation depends on clinical setting. See Viral Hepatitis Serologic Profiles.

Interpretation
Provides information to assist in interpretation of the test results

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.

 

Hepatitis B surface 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 hepatitis Be antigen (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. Hepatitis Be antibody (anti-HBe) positivity in a carrier is often associated with chronic asymptomatic infection.

 

If the patient has a sudden exacerbation of disease, consider ordering hepatitis C virus antibody (anti-HCV) and hepatitis delta virus antibody (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

-Viral Hepatitis Serologic Profiles

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

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 FDA 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

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

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 September 29, 2020. Available at www.who.int/hepatitis/publications/guidelines-hepatitis-c-b-testing/en/

8. Centers for Disease Control and Prevention. Testing and public health management of persons with chronic hepatitis B virus infection. Accessed April 8, 2020. Available at www.cdc.gov/hepatitis/hbv/testingchronic.htm

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:

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, 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)

 

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, version 9.1. Ortho-Clinical Diagnostics, Inc; 09/06/2019)

 

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, version 9.1. 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.

1 to 4 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.

86707

87340

87350

87341 (if appropriate)

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

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

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