Test ID: HBABT
Hepatitis B Surface Antibody Monitor, Post-Transplant, Serum
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Monitoring serum anti-hepatitis B surface levels during intravenous or intramuscular hepatitis B immune globulin therapy to prevent recurrence of hepatitis B virus infection in liver transplant recipients
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
See HBV Infection-Monitoring Before and After Liver Transplantation in Special Instructions.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
Chemiluminescent Immunoassay (CIA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Antibody Titer to Hep B Surface Ag
Antibody to Hepatitis B Surface Antigen
HBV (Hepatitis B Virus)
Hep B Surface Ab (Anti-HBs) Titer, S
Hepatitis B Surface Antibody-Quant
Hepatitis B Virus (HBV)
Hepatitis Bs
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Additional Information: Date of draw is required.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross reject |
| Lipemia | Mild OK; Gross reject |
| Icterus | Mild OK; Gross reject |
| Other | Plasma |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum SST | Frozen (preferred) | |
| Refrigerated | 7 days | |
| Ambient | 24 hours | |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
For patients with chronic hepatitis B virus (HBV) infection (hepatitis B surface antigen-positive), outcomes following liver transplantation for end-stage liver disease are poor. Recurrent HBV disease 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 HBV infection in these transplant recipients.
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 (US) since mid-1990. 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 surface antibody (anti-HBs) levels of >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.
There is a high degree of variability in HBIG dosage required to achieve desirable serum anti-HBs levels among transplant recipients during the first few weeks to months after transplantation. Patients who were hepatitis B envelope (HBe) 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 <12 months of therapy usually combine HBIG with another effective anti-HBV agent such as lamivudine.
See HBV Infection-Monitoring Before and After Liver Transplantation 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.
Not applicable
Interpretation Provides information to assist in interpretation of the test results
Please refer to institutional hepatitis B immune globulin (HBIG) therapy protocol for desirable anti-hepatitis B surface (anti-HBs) levels.
Studies indicated that serum anti-HBs levels needed to prevent hepatitis B virus reinfection were >500 mIU/mL during the first week after transplantation, >250 mIU/mL during weeks 2 to 12, and >100 mIU/mL after week 12.
See HBV Infection-Monitoring Before and After Liver Transplantation in Special Instructions.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Not useful for determining previous exposure to hepatitis B virus (HBV) or determining adequate immunity from HBV vaccination; order HBAB/8254 Hepatitis B Surface Antibody, Qualitative/Quantitative, Serum for those situations.
This test does not provide interpretation of the hepatitis B surface (HBs) antibody level to determine immune status. Order HBAB/8254 Hepatitis B Surface Antibody, Qualitative/Quantitative, Serum for determination of immune status.
Previous hepatitis B infection or vaccination and passively acquired anti-HBs from transfusion of whole blood or plasma can contribute to measurable anti-HBs levels.
Not useful for the diagnosis of acute HBV infection.
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 >3,000 mg/dL)
-Grossly hemolyzed (hemoglobin level of >500 mg/dL)
-Containing particulate matter
-Cadaveric specimens
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Samuel D: Management of hepatitis B in liver transplant patients. Semin Liver Dis 2004;24(suppl 1):55-62
2. Terrault NA, Vyas G: Hepatitis B immune globulin preparations and use in liver transplantation. Clin Liver Dis 2003;7:537-550
3. Lok AS: Prevention of recurrent hepatitis B post-liver transplantation. Liver Transpl 2002;8:S67-S73
Method Description Describes how the test is performed and provides a method-specific reference
VITROS Anti-HBs Quantitative assay is performed using the VITROS Anti-HBs Quantitative Reagent Pack and VITROS Immunodiagnostic Products Anti-HBs Calibrators on the automated VITROS Immunodiagnostic System.
This chemiluminescence immunoassay is based on an immunometric technique in which the anti-hepatitis B surface (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 VITROS Immunodiagnostic System. The amount of HRP conjugate bound is directly proportional to the concentration of anti-HBs present.
Specimens yielding anti-HBs antibody titers of >1,000 mIU/mL on initial testing will be retested after a dilution of 1:100 by the automated Vitros Immunodiagnostic System.(Package insert: Publication no. GEM1208_EN, v 2.0; VITROS Anti-HBs Quantitative Assay, Ortho-Clinical Diagnostics, Inc., Rochester, NY)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Saturday; Varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
86317
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| HBABT | HBs Ab Monitor, Post-transplant, S | 32019-2 |
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