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Hepatitis B Virus (HBV) Genotyping Plus Drug Resistance
CPT:
87900; 87912
Synonyms
- HBV Genotype, PreCore and Resistance
- HBV Resistance Testing
Expected Turnaround Time
7 - 12 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
Specimen Requirements
Specimen
Plasma or serum, frozen
Volume
1.2 mL
Minimum Volume
600 μL
Container
Gel-barrier tube, yellow-top (ACD) tube, lavender-top (EDTA) tube or PPT.
Collection
Centrifuge sample within six hours of collection, transfer plasma/serum to a polypropylene screw-cap tube and freeze. To avoid delays in turnaround time, when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.
Storage Instructions
Freeze.
Causes for Rejection
Quantity not sufficient for analysis; heparin/SPS plasma (wrong anticoagulant); gross hemolysis; specimen not frozen
Test Details
Use
Data generated in the genotyping assay is subsequently analyzed for mutations in the reverse transcriptase gene of HBV associated with resistance to therapeutic agents, and if identified an interpretation of their clinical significance provided.
Limitations
This assay may not be successful when the HBV viral load is <500 IU/mL.
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.
Methodology
Polymerase chain reaction (PCR) amplification and DNA sequencing
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 551750 | HBV Genotype + Drug Resistance | 551535 | **HBV Genotype | 32366-7 | ||
| 551750 | HBV Genotype + Drug Resistance | 551536 | **HBV PreCore Mutation | 54210-0 | ||
| 551750 | HBV Genotype + Drug Resistance | 551537 | **HBV Drug Resistance Mutation | 43279-9 | ||
| 551750 | HBV Genotype + Drug Resistance | 551538 | **3TC [Lamivudine, Epivir] | 30283-6 | ||
| 551750 | HBV Genotype + Drug Resistance | 551539 | **ADV [Adefovir, Hepsera] | 30288-5 | ||
| 551750 | HBV Genotype + Drug Resistance | 551559 | **TEB [Telbivudine, Tyzeka] | 56792-5 | ||
| 551750 | HBV Genotype + Drug Resistance | 551562 | **ETV [Entecavir, Baraclude] | 56791-7 | ||
| 551750 | HBV Genotype + Drug Resistance | 551563 | **TNF [Tenofovir, Viread] | 41396-3 |
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CPT Statement/Profile Statement
The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf