Test Catalog

Test Id : HBABY

Hepatitis B Perinatal Exposure Follow-up Panel, Serum

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

Determining hepatitis B virus infection and immunity status (with or without perinatal prophylaxis) in infants born to mothers with chronic hepatitis B

Highlights

This test should be ordered for infants born to mothers with chronic hepatitis B only.

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

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.

 

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

Hepatitis B Perinatal Exposure, S

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

Hepatitis Screen

Postnatal HBV

HBABY

Hepatitis Profile

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.

 

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

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.

2. Aliquot serum into plastic vial.

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

Forms

If not ordering electronically, complete, print, and send a Gastroenterology and Hepatology Client Test Request (T728) with the specimen.

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

Determining hepatitis B virus infection and immunity status (with or without perinatal prophylaxis) in infants born to mothers with chronic hepatitis B

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.

 

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. After a course of acute illness, HBV persists in about 10% of patients who were infected during adulthood. Some carriers are asymptomatic; 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, but 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 hepatitis B e antigen (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 addicts). The virus is found in virtually every type of human body fluid and also is spread through oral and genital contact.

 

See the following in Special Instructions:

-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.

Negative

See Viral Hepatitis Serologic Profiles in Special Instructions.

Interpretation
Provides information to assist in interpretation of the test results

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.

 

Hepatitis B 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.(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.

 

See the following in Special Instructions:

-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

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. 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 2, 2020. 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. Accessed April 8, 2020. 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. 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 September 29, 2020. Available at www.who.int/hepatitis/publications/guidelines-hepatitis-c-b-testing/en/

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

 

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, version 14.1. Ortho-Clinical Diagnostics, Inc; 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 a 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 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, 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)

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
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

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 | Create a 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