Hepatitis B Virus DNA Quantitative PCR, Serum/Plasma
Test Overview
Clinical Utility
This test is intended for use in conjunction with clinical presentation and other laboratory markers for the clinical management of patients with chronic HBV infection undergoing antiviral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment.
The cobas® HBV Test is not intended for use as a screening test for the presence of HBV in blood or blood products or as a diagnostic test to confirm the presence of HBV infection.
Method
Real-Time Polymerase Chain Reaction (PCR)
Result Included
Hepatitis B Virus DNA
Specimen
Specimen Type
SerumPlasma
Containers
Preferred Containers
Lavender top (EDTA)
Acceptable Containers
Gold top (clot activator & gel);Red top (no additive)
Volume
Sample Volume
3 mL
Minimum Volume
1 mL
Collection & Handling
Handling Information
Freshly drawn specimens (whole blood) may be stored at 2 – 25 °C for up to 24 hours prior to centrifugation. Separate plasma or serum from cells within 24 hours of collection by centrifugation. Store and send frozen.
Stability
| Ambient | Refrigerated | Frozen |
|---|---|---|
| Unacceptable | 6 days | 84 days |
Rejection Criteria
| Criteria | Specification |
|---|---|
| Specimen | Not separated within 24 hours of collection |
Performance & Interpretation
Turnaround Time
10 days
Results
-
Hepatitis B Virus DNAIU/mLNot Detected
-
Hepatitis B Virus DNALog IU/mlNot Detected
Comment
Reportable range is 10 to 1,000,000,000 IU/mL (1.00 - 9.00 Log IU/mL)
Referral Location
Out-of-Country
Interface & Setup
HL7 Interface Codes
| Order Code | Result Name | Result Codes | Units |
|---|---|---|---|
| HEPPCRQUANT | HEPATITIS B VIRUS DNA | 62112 | IU/mL |
| HEPATITIS B VIRUS DNA | 62113 | Log IU/mL |
Test Version
Last Updated
2023-02-01