Intended Use
This HBV assay is based on in vitro polymerase chain reaction (PCR) for the quantitation of Hepatitis B Virus (HBV) DNA.
Specimen Required
Do not freeze the whole blood/plasma. Transport 4 mL whole blood or 2 mL plasma. (Min: 1 mL)
Patient Preparation
- Sample Collection: Whole blood in lavender (EDTA). Collection of blood sample before dialysis is preferred.
- Specimen Preparation: Do not freeze the whole blood/plasma. Transport 4 mL whole blood or 2 mL plasma. (Min: 1 mL)
- Storage/Transport Temperature: Refrigerated
- Unacceptable Conditions
- Serum, CSF
- Collected in incorrect tubes (e.g., with additives that inhibit PCR).
- Haemolyzed, icteric, lipemic, or Heparinized specimens.
- Insufficient volume, leaked, or improperly stored.
- Remarks: Proper aseptic technique and sample handling are critical to avoid contamination or degradation.
- Stability: After separation from cells: Ambient: 24 hours; Refrigerated: 6 days; Frozen: 3 months.
Methodology
The assay uses real-time PCR targeting a highly conserved region of the HBV Surface gene, enabling quantitation of DNA from all HBV genotypes. Quantification is standardized to WHO International Standards and reported in IU/mL or copies/mL.
Sample Received to Report Turnaround Time (TAT)
Twice in a Week (Scheduled Test)
Interpretive Data
Refer to the Report.
Resources
- Additional Technical Information
- Test Request Form
Sample Reports
- Enhanced Report
- See report