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| UWHC Lab Test Details | |
|---|---|
| Test Name | Hepatitis B DNA, Quantitative (Viral Load) |
| Test Code(s) | XHBVD |
| CPT Code(s) | 87517 |
| Methodology | Aptima |
| Clinical Information | The Aptima HBV Quant assay is an in vitro nucleic acid amplification test that uses real time transcription-mediated amplification (TMA) technology on the Panther system to quantitate HBV DNA, genotypes A, B, C, D, E, F, G, and H. |
| Days Performed | Once a week. |
| In-Lab Turnaround Time | 10 days. |
| Stat In-Lab Turnaround Time | Not available stat. |
| Collection Requirements | |||||
|---|---|---|---|---|---|
| Specimen | Blood | ||||
| Collection Container |
| ||||
| Collection Volume | 6 mL | ||||
| Pediatric Collection Volume | 2 mL | ||||
| Specimen Processing Requirements | |||||||
|---|---|---|---|---|---|---|---|
| Stability |
| ||||||
| Sample Analyzed | Plasma | ||||||
| Testing Volume | 3 mL | ||||||
| Pediatric Testing Volume | 1.2 mL | ||||||
| Specimen Processing | Separate cell-free plasma from whole blood and transfer plasma to a sterile polypropylene tube or inpeco tube within 24 hours of collection. EDTA plasma may be stored at 2°C to 8°C for up to 5 days or Frozen at -20°C for up to 60 days. | ||||||
| Outreach Specimen Processing | Transport frozen plasma specimen on dry ice to Laboratory. | ||||||
| Specimen Transport | Transport specimen to laboratory immediately. | ||||||
| Unacceptable Criteria | LIMIT: One specimen every 48 hours. | ||||||
| Interpretation | |
|---|---|
| Expected Results | Not detected.
If HBV is detected within the analytical measurement range, two results are reported for each assay: a measured International units/mL and a calculated log international units/mL result.
Analytical measurement range of this assay is 10 - 1,000,000,000 International units (IU)/mL (1.00-9.00) log International units (IU)/mL). In patients where HBV is detected but outside of the analytical measurement range (AMR), a result <10 IU/mL or > 1,000,000,000 IU/mL will be reported. If no HBV is detected, a result of "HBV not detected" will be reported.
|
| Test Limitations | This test does not genotype the virus.
Though rare, mutations within the highly conserved regions of the viral genome covered by the primers and/or probes in the Aptima HBV Quant assay may result in failure to detect the virus. |
| Additional Information | Specimens are assayed using the Hologic Aptima HBV Quant Assay.
This test is approved by the U.S. Food and Drug Administration. |
