Test Catalog

Test Id : HBAB

Hepatitis B Surface Antibody, Qualitative/Quantitative, Serum

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

Identifying previous exposure to hepatitis B virus

 

Determining adequate immunity from hepatitis B vaccination

Highlights

This assay provides both qualitative and quantitative results.

 

This diagnostic test should be used for testing individuals to evaluate post-vaccination immunity status or post-acute infection status of hepatitis B virus.

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

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

Chemiluminescent 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

HBs Antibody, S

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

Antibody to Hepatitis B Surface Ag

HBsAb

Hepatitis B Surface Antibody

Hepatitis B Surface Antibody-Quant

Hepatitis Bs Ab

Anti-HBs

HBAB

Hepatitis B Surface Ab

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

Specimen Type
Describes the specimen type validated for testing

Serum SST

Ordering Guidance

If patient is being monitored for hepatitis B immune globulin (HBIG) therapy after organ transplantation, order HBABT / Hepatitis B Surface Antibody Monitor, Post-Transplant, Serum.

 

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 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

Forms

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

-General Request (T239)

-Gastroenterology and Hepatology Client Test Request (T728)

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

0.5 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

Identifying previous exposure to hepatitis B virus

 

Determining adequate immunity from hepatitis B vaccination

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

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

Hepatitis B virus (HBV) infection, also known as serum hepatitis, is endemic throughout the world. The infection is spread primarily through blood transfusion or percutaneous contact with infected blood products, such as sharing of needles among injection drug users. The virus is also found in virtually every type of human body fluid and has been 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, but it is not commonly transmitted via the transplacental route.

 

The incubation period for HBV infection averages 60 to 90 days (range of 45-180 days). Common symptoms include malaise, fever, gastroenteritis, and jaundice (icterus). After acute infection, HBV infection becomes chronic in 30% to 90% of infected children younger than 5 years of age and in 5% to 10% of infected individuals age 5 years or older. Some of these chronic carriers are asymptomatic, while others progress to chronic liver disease, including cirrhosis and hepatocellular carcinoma.

 

Hepatitis B surface antigen (HBsAg) is the first serologic marker, appearing in the serum 6 to 16 weeks following HBV infection. In acute cases, HBsAg usually disappears 1 to 2 months after the onset of symptoms with the appearance of hepatitis B surface antibody (anti-HBs). Anti-HBs also appears as the immune response following hepatitis B vaccination.

 

See HBV Infection-Diagnostic Approach and Management Algorithm in Special Instructions

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 ANTIBODY

Unvaccinated: negative

Vaccinated: positive

 

HEPATITIS B SURFACE ANTIBODY, QUANTITATIVE

Unvaccinated: <5.0 mIU/mL

Vaccinated: > or =12.0 mIU/mL

 

See Viral Hepatitis Serologic Profiles in Special Instructions.

Interpretation
Provides information to assist in interpretation of the test results

A positive result indicates recovery from acute or chronic hepatitis B virus (HBV) infection or acquired immunity from HBV vaccination. This assay does not differentiate between a vaccine-induced immune response and an immune response induced by infection with HBV. A positive total antihepatitis B core (anti-HBc) result would indicate that the hepatitis B surface antibody (anti-HBs) response is due to past HBV infection.

 

Per assay manufacturer's instructions for use, positive results, defined as anti-HBs levels of 12.0 mIU/mL or greater, indicate adequate immunity to HBV from past hepatitis B viral infection or HBV vaccination. However, per current CDC guidance,(1) individuals with anti-HBs levels greater than 10 mIU/mL after completing an HBV vaccination series are considered protected from hepatitis B.

 

Negative results, defined as anti-HBs 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. The US Advisory Committee on Immunization Practices does not recommend more than 2 HBV vaccine series in nonresponders.

 

Indeterminate results, defined as anti-HBs levels in the range from 5 to 11.9 mIU/mL, indicate inability to determine if anti-HBs is present at levels consistent with recovery or immunity. Repeat testing is recommended in 1 to 3 months.

 

See -HBV Infection-Diagnostic Approach and Management Algorithm in Special Instructions.

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

Individuals who have received blood component therapies (eg, whole blood, plasma, or intravenous immunoglobulin infusion) in the previous 3 to 6 months may have false-positive hepatitis B surface antibody (anti-HBs) results due to passive transfer of anti-HBs present in these products.

 

Individuals possessing IgM anti-rubella virus may have falsely high results with the VITROS Anti-HBs quantitative test.

 

Anti-HBs levels from past hepatitis B or hepatitis B virus (HBV) vaccination may fall below detectable levels over time.

 

A positive anti-HBs result does not exclude infection by another hepatitis virus.

 

Performance characteristics have not been established for the following specimen characteristics:

-Grossly icteric (total bilirubin level of >20 mg/dL)

-Grossly lipemic (triglyceride level of >3000 mg/dL)

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

-Containing particulate matter

-Cadaveric specimens

-Body fluids other than serum (eg, saliva, urine, CSF, amniotic, peritoneal, or pleural fluids)

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

1. Advisory Committee on Immunization Practices; Centers for Disease Control and Prevention: 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. Badur S, Akgun A: Diagnosis of hepatitis B infections and monitoring of treatment. J Clin Virol. 2001 Jun;21(3):229-237

3. Servoss JC, Friedman LS: Serologic and molecular diagnosis of hepatitis B virus. Clin Liver Dis. 2004 May;8(2):267-281

4. LeFebre 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. 2018 Jul;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: WHO guidelines on hepatitis B and C testing. World Health Organization; 2017. Accessed July 8, 2021. Available at www.who.int/publications/i/item/9789241549981

8. Centers for Disease Control and Prevention: Testing and public health management of persons with chronic hepatitis B virus infection. CDC; Updated October 8, 2019. Accessed April 8, 2020. Available at www.cdc.gov/hepatitis/hbv/testingchronic.html

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

VITROS hepatitis B surface antibody (anti-HBs) quantitative 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_US_EN, 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

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