Test Details
Methodology
Polymerase chain reaction (PCR) amplification and DNA sequencing
Result Turnaround Time
7 - 10 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
The HBV genotype assay classifies the virus present in the sample into one of nine recognized genotypes (A-I) via sequence analysis of the DNA polymerase gene. Disease progression and response to therapy may be influenced by genotype. In addition, the HBV genotype assay identifies and reports sequence polymorphisms in the basal core promotor (BCP) and coding regions of the HBV precore gene that result in either decreased levels, or complete absence, of HBeAg expression in chronically infected patients.
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 Food and Drug Administration. 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 |
|---|---|---|---|---|---|---|
| 551710 | HBV Genotype | 551578 | HBV Genotype | 32366-7 | ||
| 551710 | HBV Genotype | 551714 | HBV PreCore Mutation | 54210-0 | ||
| Order Code | 551710 | |||||
| Order Code Name | HBV Genotype | |||||
| Order Loinc | ||||||
| Result Code | 551578 | |||||
| Result Code Name | HBV Genotype | |||||
| UofM | ||||||
| Result LOINC | 32366-7 | |||||
| Order Code | 551710 | |||||
| Order Code Name | HBV Genotype | |||||
| Order Loinc | ||||||
| Result Code | 551714 | |||||
| Result Code Name | HBV PreCore Mutation | |||||
| UofM | ||||||
| Result LOINC | 54210-0 |