Test Catalog

Test Id : HBABT

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Hepatitis B Virus Surface Antibody Monitor, Post-Transplant, Serum

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Overview

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

Monitoring serum hepatitis B virus surface antibody levels during intravenous or intramuscular hepatitis B immune globulin therapy to prevent hepatitis B virus reinfection in liver transplant recipients with known previous chronic hepatitis B

Highlights

This test provides quantitative results only; this test does not provide interpretation of the hepatitis B surface antibody level detected.

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 Ab Monitor, Post-transplant, S

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

Anti-Hepatitis Bs

Antibody Titer to Hep B Surface Ag

Antibody to Hepatitis B Surface Antigen

HBV (Hepatitis B Virus)

Hepatitis B Surface Antibody-Quant

Hepatitis B Virus (HBV)

Hepatitis Bs

Hep B Surface Ab (Anti-HBs) Titer

HBABT

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

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 (red-top tubes are not acceptable)

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. The minimum volume is sufficient for one attempt at testing.

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
Heat-inactivated specimen 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) 90 days
Refrigerated 6 days
Ambient 7 hours

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

Monitoring serum hepatitis B virus surface antibody levels during intravenous or intramuscular hepatitis B immune globulin therapy to prevent hepatitis B virus reinfection in liver transplant recipients with known previous chronic hepatitis B

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

For patients with chronic hepatitis B, outcomes following liver transplantation for end-stage liver disease are poor. Recurrent hepatitis B is common and associated with decreased liver graft and patient survival (approximately 50% at 5 years). Studies have shown administration of hepatitis B immune globulin (HBIG) in the perioperative and early posttransplant periods could delay or prevent recurrent hepatitis B virus (HBV) infection in these transplant recipients.

 

Since mid-1990, intravenous or intramuscular administration of HBIG has become the standard of care for these liver transplant recipients in most liver transplant programs in the United States. Most therapy protocols administer HBIG in high doses (10,000 IU) during the perioperative period and first week after transplantation with the goal of achieving serum hepatitis B virus surface antibody (anti-HBs) levels of above 500 mIU/mL. Serial levels of anti-HBs are obtained to determine the pharmacokinetics of HBIG in each patient to guide frequency of HBIG dosing.

 

During the first few weeks to months after transplantation, there is a high degree of variability in HBIG dosage required to achieve desirable serum anti-HBs levels among transplant recipients. Patients who were hepatitis B e antigen positive before transplantation usually require more HBIG to achieve the target anti-HBs levels, especially in the first week after transplantation.

 

Duration of HBIG therapy varies from 6 months to indefinite among different US liver transplant programs. Protocols providing less than 12 months of therapy usually combine HBIG with another effective anti-HBV agent, such as lamivudine.

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.

Not applicable

Interpretation
Provides information to assist in interpretation of the test results

Refer to the healthcare provider's institutional hepatitis B immune globulin (HBIG) therapy protocol for desirable hepatitis B virus surface antibody (anti-HBs) levels.

 

Studies indicated that serum anti-HBs levels needed to prevent hepatitis B virus reinfection were greater than 500 mIU/mL during the first week after transplantation, greater than 250 mIU/mL during weeks 2 to 12, and greater than 100 mIU/mL after week 12.

 

For more information see HBV Infection-Monitoring Before and After Liver Transplantation

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

This assay has not been licensed by the US Food and Drug Administration for the screening of blood, plasma, and tissue donors.

 

Results obtained with the Elecsys Anti-HBs immunoassay may not be used interchangeably with values obtained with different manufacturers’ assay methods.

 

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination, and other findings.

 

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. In rare cases, interference due to high titers of antibodies to immunological components, streptavidin or ruthenium can occur, causing false-positive anti-HBs results.

 

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.

 

 Results obtained with the Elecsys Anti-HBs immunoassay may not be used interchangeably with values obtained with different manufacturers’ assay methods.

 

Assay performance characteristics have not been established for the following specimen characteristics or specimen types:

-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

-Specimen types other than serum

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

1. Nasir M, Wu GY. Prevention of HBV recurrence after liver transplant: a review. J Clin Translat Hepatol. 2020;8(2):150-160

2. Te H, Doucette K. Viral hepatitis: guidelines by the American Society of Transplantation Infectious Disease Community of Practice.  Clin Transplant. 2019;33(9):e13514. doi:10.1111/ctr.13514

3. 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; v3.0, 03/2024)

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.

86317

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
HBABT HBs Ab Monitor, Post-transplant, 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.
HBABT HBs Ab Monitor, Post-transplant, S 5193-8

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

Test Update Resources

Change Type Effective Date
Test Changes - Specimen Information 2024-05-28
Test Changes - Method 2024-04-18