Test Details
Methodology
Polymerase chain reaction (PCR) amplification and DNA sequencing
Result 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.
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.
Specimen Requirements
Specimen
Plasma or serum, frozen
Volume
1.2 mL
Minimum Volume
600 μL (Note: This volume does not allow for repeat testing.)
600 μL |
600 μL (Note: This volume does not allow for repeat testing.) |
Container
Gel-barrier tube, yellow-top (ACD) tube, lavender-top (EDTA) tube or PPT
Gel-barrier tube, yellow-top (ACD) tube, lavender-top (EDTA) tube or PPT |
Gel-barrier tube, yellow-top (ACD) tube, lavender-top (EDTA) tube or PPT |
Collection Instructions
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
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 | ||
| Order Code | 551750 | |||||
| Order Code Name | HBV Genotype + Drug Resistance | |||||
| Order Loinc | ||||||
| Result Code | 551535 | |||||
| Result Code Name | **HBV Genotype | |||||
| UofM | ||||||
| Result LOINC | 32366-7 | |||||
| Order Code | 551750 | |||||
| Order Code Name | HBV Genotype + Drug Resistance | |||||
| Order Loinc | ||||||
| Result Code | 551536 | |||||
| Result Code Name | **HBV PreCore Mutation | |||||
| UofM | ||||||
| Result LOINC | 54210-0 | |||||
| Order Code | 551750 | |||||
| Order Code Name | HBV Genotype + Drug Resistance | |||||
| Order Loinc | ||||||
| Result Code | 551537 | |||||
| Result Code Name | **HBV Drug Resistance Mutation | |||||
| UofM | ||||||
| Result LOINC | 43279-9 | |||||
| Order Code | 551750 | |||||
| Order Code Name | HBV Genotype + Drug Resistance | |||||
| Order Loinc | ||||||
| Result Code | 551538 | |||||
| Result Code Name | **3TC [Lamivudine, Epivir] | |||||
| UofM | ||||||
| Result LOINC | 30283-6 | |||||
| Order Code | 551750 | |||||
| Order Code Name | HBV Genotype + Drug Resistance | |||||
| Order Loinc | ||||||
| Result Code | 551539 | |||||
| Result Code Name | **ADV [Adefovir, Hepsera] | |||||
| UofM | ||||||
| Result LOINC | 30288-5 | |||||
| Order Code | 551750 | |||||
| Order Code Name | HBV Genotype + Drug Resistance | |||||
| Order Loinc | ||||||
| Result Code | 551559 | |||||
| Result Code Name | **TEB [Telbivudine, Tyzeka] | |||||
| UofM | ||||||
| Result LOINC | 56792-5 | |||||
| Order Code | 551750 | |||||
| Order Code Name | HBV Genotype + Drug Resistance | |||||
| Order Loinc | ||||||
| Result Code | 551562 | |||||
| Result Code Name | **ETV [Entecavir, Baraclude] | |||||
| UofM | ||||||
| Result LOINC | 56791-7 | |||||
| Order Code | 551750 | |||||
| Order Code Name | HBV Genotype + Drug Resistance | |||||
| Order Loinc | ||||||
| Result Code | 551563 | |||||
| Result Code Name | **TNF [Tenofovir, Viread] | |||||
| UofM | ||||||
| Result LOINC | 41396-3 |