| SPECIMEN REQUIREMENTS |
|
| Container Type |
Lavender top tube (EDTA) or Red top tube (plain) |
| Specimen Type |
Frozen EDTA plasma or frozen serum. |
| Preferred Volume |
3 mL |
| Minimum Volume |
2 mL |
| Specimen Processing |
Separate plasma or serum from cells within 6 hours of collection by centrifugation at 800-1600 x g for 20 minutes at room temperature and put in separate sterile polypropylene tube and freeze immediately. Store and transport frozen. Ship 650  |
| Stability |
Room Temp 3 days Refrigerated 1 week Frozen (-20°C) 6 weeks Frozen (-70°C) 6 weeks |
| Unacceptable Conditions |
Cannot be ordered as a reflex or add on test on serum or plasma previously tested, other than branch DNA testing. Whole blood, heparinized or unfrozen specimens are not acceptable. Do not allow sample to thaw. |
| Alternate Specimens |
PPT tube. Centrifuge and pour plasma sample into sterile polypropylene tube and freeze. Store and transport frozen. |
| Limitations |
This test cannot be ordered as a reflexive test on serum or plasma samples previously tested for antibodies. A dedicated sample is required for molecular testing. |
| Department |
Molecular Diagnostics |
| Reference Laboratory |
PSHMC |
| CPT Codes |
87517 |
| Test Schedule |
Mon, Thu |
| Turnaround Time |
3-6 days |
| Method |
RT-PCR |
| Test Includes |
Hepatitis B Virus DNA Quant Result, IU/mL; Hepatitis B Virus DNA Quant Log 10 value, IU/mL; Hepatitis B Virus DNA Quantitative Methodology; Hepatitis B Virus DNA Quantitative Comment. |
| Reference Ranges |
HBV DNA Quant Result IU/mL
Not detected
This result does not rule out the presence of HBV DNA
below the limit of detection of this assay. Inaccurate
results can occur due to improper specimen handling or
the presence of PCR inhibitors in the patient sample.
HBV DNA Quant Log 10 Value IU/mL
Not Detected
HBV DNA Quant Methodology
This assay is performed using real time
PCR by the COBAS TaqMan HBV IVD test.
HBV DNA Quant Comment
The reportable range of this test is
29-11,000,000,000 IU/mL (Log 10 1.5-10.0).
The limit of detection is 10 IU/mL.
|
| Compliance Remarks |
This test is performed pursuant to an agreement with Roche Molecular Systems. This test is FDA approved and is intended for in vitro diagnostic use. |
:: Interface Codes ::
| type | order code | test description | result code | result description | units | decimal places | loinc code |
| o | 87517.Z15 | HBV DNA Quant by PCR |
| r | 87517.Z15 | HBV DNA Quant by PCR | 87517.Z11 | Result | IU/mL | 1 | 42595-9 |
| r | 87517.Z15 | HBV DNA Quant by PCR | 87517.Z12 | Log10 value | | | 42595-9 |
| r | 87517.Z15 | HBV DNA Quant by PCR | 87517.Z13 | Methodology | | | 42595-9 |
| r | 87517.Z15 | HBV DNA Quant by PCR | 87517.Z14 | Comment | | | 42595-9 |
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