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HelpTest Code SOFT: Z1000 Hepatitis B Virus Surface Antibody Monitor, Post-Transplant, Serum
Additional Codes
| Ordering Mnemonic | Mayo Test ID |
|---|---|
| EPIC NAME: MISC. LAB TEST | HBABT |
EPIC CODE: LAB000
Reporting Name
HBs Ab Monitor, Post-transplant, SUseful For
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
For more information see HBV Infection-Monitoring Before and After Liver Transplantation.
Method Name
Electrochemiluminescence Immunoassay (ECLIA)
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
Serum SSTNecessary Information
Date of collection is required.
Specimen Required
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.
Specimen Minimum Volume
0.6 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum SST | Frozen (preferred) | 90 days | |
| Refrigerated | 6 days | ||
| Ambient | 7 hours |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
| Heat-inactivated specimen | Reject |
Special Instructions
Reference Values
Not applicable
Day(s) Performed
Monday through Saturday
CPT Code Information
86317
LOINC Code Information
| 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 |
|---|---|---|
| HBABT | HBs Ab Monitor, Post-transplant, S | 5193-8 |
Test Classification
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.Clinical Information
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.
Interpretation
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
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
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
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)
Report Available
Same day/1 to 3 daysSpecimen Retention Time
14 daysForms
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Highlights
This test provides quantitative results only; this test does not provide interpretation of the hepatitis B surface antibody level detected.