Assay Name: HBV DNA Quantitation
Alias/Synonyms: HBV, Hepatitis, Hep B
Additional Information: Quantitative
Epic order code: LAB5302
Specimen Collection and Storage
Acceptable Tubes:
- EDTA or ACD anticoagulant tubes
- Plasma Preparation Tubes (PPTs)
- Serum tubes or Serum Separator Tubes (SSTs)
For serum, allow clot formation before processing.
A. Specimen Collection
- Store whole blood at 2–30°C and centrifuge within 24 hours.
- Separate plasma or serum per tube manufacturer’s instructions.
- Minimum volume: 700 µL (not sufficient for repeat testing).
- If not tested immediately, transfer plasma/serum to a plastic secondary tube and freeze at -20°C.
- Do not freeze in primary EDTA, ACD, or serum tubes.
- Limit to 3 freeze–thaw cycles.
B. Specimen Storage Conditions After Centrifugation
| Tube type | Room Temp (2–25°C) | Refrigerated (2–8°C) | Frozen (-20°C) |
|---|---|---|---|
| EDTA/ACD Plasma | Up to 24 hrs | Up to 5 days | Up to 60 days (secondary tube only) |
| PPT | Up to 24 hrs | Up to 5 days | Up to 60 days |
| Serum Tubes | Up to 24 hrs | Up to 5 days | Up to 60 days (secondary tube only) |
| SST | Up to 24 hrs | Up to 5 days | Up to 60 days |
Unacceptable conditions: Clotted or frozen blood
Plasma or Serum Volume less than 650 μL
Whole blood more than 24 hours old that has not been spun
Use: The Aptima HCV Quant Dx assay is indicated for use as an aid in the diagnosis of active HCV infection in the following populations: individuals with antibody evidence of HCV infection with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV.
Methodology: real time transcription-mediated amplification (TMA)
Reported: 5 -7 business days from receipt of the specimen
CPT Code: 87517
Test Classification: FDA Approved