Hepatitis B Virus (HBV) DNA Detection and Quantification by Real-Time PCR, Serum
Use
This test is useful for the detection and quantification of hepatitis B virus (HBV) DNA in the serum of patients with chronic HBV infection, particularly those who are hepatitis B surface antigen-positive. It is used to monitor disease progression in chronic HBV infection and to evaluate the patient's response to anti-HBV therapy. The presence of HBV DNA in serum is a reliable marker of active HBV replication, which is crucial for differentiating between active and inactive disease states in chronic HBV infections.
Special Instructions
Not provided.
Limitations
This test is not licensed by the FDA as a screening test for HBV infections. HBV serologic testing should be performed to initiate HBV infection status evaluation. The diagnosis of chronic HBV infection should not be based solely on a single serum specimen with detectable or quantifiable HBV DNA. An undetected HBV DNA test result does not exclude the possibility of a resolved infection, especially in cases with positive anti-HBV antibody status. Retesting in 1 to 2 months may be necessary to distinguish between resolved and chronic infections with episodic replication.
FDA ApprovedNew York Approved
Methodology
PCR-based (Real-Time PCR)
Biomarkers
Hepatitis B Virus (HBV)
Microorganism
LOINC Codes
- 42595-9 - HBV DNA SerPl NAA+probe-aCnc
- 42595-9 - HBV DNA SerPl NAA+probe-aCnc
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
1.5 mL
Minimum Volume
0.8 mL
Container
Plastic vial
Collection Instructions
Centrifuge blood collection tube per manufacturer's instructions. Aliquot serum into a plastic vial.
Storage Instructions
Ship specimen frozen on dry ice. If delayed >24 hours, freeze at -20 to -80°C.
Causes for Rejection
Gross hemolysis.
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 6 days |
| Frozen | 84 days |