Test Catalog

Test Id : HBBSN

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Hepatitis B Virus Surface Antibody Screen, Qualitative/Quantitative, Serum

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Overview

Test Catalog

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

Identifying previous exposure to hepatitis B virus

Highlights

This assay provides both qualitative and quantitative results.

 

This test should be used for screening asymptomatic, nonpregnant individuals with or without risk factors for hepatitis B virus infection.

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

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

Electrochemiluminescence Immunoassay (ECLIA)

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 Scrn, S

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

Anti-HBs screen

Antibody to Hepatitis B Surface Ag screen

HBBSNx

HBsAb screen

Hepatitis B Surface Ab screen

Hepatitis B Surface Antibody screen

Hepatitis B Surface Antibody-Quant screen

Hepatitis Bs Ab screen

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 Virus Surface Antibody Monitor, Post-Transplant, Serum.

 

This test should not be used for prenatal screening of pregnant individuals with or without risk factors for hepatitis B virus (HBV) infection. For testing such, order HBABP / Hepatitis B Virus Surface Antibody Prenatal, Qualitative/Quantitative, Serum.

 

This test should not be used for diagnostic testing of symptomatic individuals to evaluate post-vaccination immunity status or post-acute infection status of HBV. For testing such patients, order HBAB / Hepatitis B Virus Surface Antibody, Qualitative/Quantitative, 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

Patient Preparation: For 24 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 0.7 mL

Collection Instructions:

1. Centrifuge blood collection tube per 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:

-Gastroenterology and Hepatology 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

0.6 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

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) is a DNA virus that is endemic throughout the world. The infection is spread primarily through blood transfusion or percutaneous contact with infected blood products, such as sharing needles among injection drug users. The virus is 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 and in 5% to 10% of infected individuals 5 years or older. Some 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 8 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.

 

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

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: <8.5 mIU/mL

Vaccinated: > or =11.5 mIU/mL

 

See Viral Hepatitis Serologic Profiles

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 HBV. A positive total hepatitis B core antibody 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 11.5 mIU/mL or greater, indicate adequate immunity to HBV from past hepatitis B or HBV vaccination. However, per current Centers for Disease Control and Prevention guidance,(1) individuals with anti-HBs levels greater than 10 mIU/mL after completing an HBV vaccination series are considered protected from hepatitis B infection.

 

Negative 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. The US Advisory Committee on Immunization Practices does not recommend more than 2 HBV vaccine series in vaccine nonresponders.

 

Indeterminate 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 is recommended in 1 to 2 months to determine definitive anti-HBs status.

 

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

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.

 

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

 

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

 

Serum specimens from individuals taking biotin supplements of 20 mg or more per day may have negative anti-HBs test results due to interference of biotin with the assay. Such individuals should stop taking these biotin-containing dietary supplements for a minimum of 12 hours before blood collection for this test.

 

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

-Grossly icteric (total bilirubin level of >30 mg/dL)

-Grossly lipemic (intralipid level of >1500 mg/dL)

-Grossly hemolyzed (hemoglobin level of >1600 mg/dL)

-Containing particulate matter

-Heat-inactivated specimens

-Cadaveric specimens

-Body fluids other than serum (eg, saliva, urine, spinal fluid, 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. 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

3. Jackson K, Locarnini S, Gish R. Diagnostics of hepatitis B virus: Standard of care and investigational. Clin Liver Dis. 2018;12(1):5-11. doi:10.1002/cld.729

4. Coffin CS, Zhou K, Terrault NA. New and old biomarkers for diagnosis and management of chronic hepatitis B virus infection. Gastroenterology. 2019;156(2):355-368. doi:10.1053/j.gastro.2018.11.037

5. WHO guidelines on hepatitis B and C testing. World Health Organization; 2017. Accessed December 19, 2023. Available at www.who.int/publications/i/item/9789241549981

6. Conners EE, Panagiotakopoulos L, Hofmeister MG, et al. Screening and Testing for Hepatitis B Virus Infection: CDC Recommendations - United States, 2023. MMWR Recomm Rep. 2023;72(1):1-25. doi:10.15585/mmwr.rr7201a1

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

The Elecsys Anti-HBs (hepatitis B surface antibody) assay is based on the sandwich immunoassay principle and performed using an electrochemiluminescent immunoassay on the automated cobas e 801 immunochemistry analyzer. Anti-HBs present in patient's sample reacts with the biotinylated HBs antigen (ad and ay subtypes) and HBs antigen (ad/ay) labeled with a ruthenium complex to form a sandwich complex. After the addition of streptavidin-coated microparticles (solid phase), the complexes bind to the 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. Unbound substances are then washed away, and voltage is applied to the electrode, which induces chemiluminescent emissions that are measured by a photomultiplier. The emission signal generated is directly proportional to the concentration of anti-HBs present in the patient's sample.(Package insert: Elecsys Anti-HBs. Roche Diagnostics; v2.0, 04/2022)

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 account representative. 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

G0499 (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
HBBSN HBs Antibody Scrn, S 5193-8
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.
HBSQN HBs Antibody, Quantitative, S 5193-8
HBASN HBs Antibody Scrn, S 10900-9

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 | PHP Pdf | CMS 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