Hepatitis B Virus (HBV) DNA, Quantitative PCR, Plasma/Serum
Test Mnemonic
HBVDNU
CPT Codes
- 87517 - QTY (1)
LOINC ®
29615-2
Aliases
- HBVDNU
- hep b
- SQHBVDNU
- viral load
- HBV DNA
- HBVDNA
Includes
- HBV DNA
- HBV DNA (IU/mL)
- HBV DNA (log IU/mL)
Performing Laboratory
Cleveland Clinic Laboratories
Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 2 mL | Plasma | EDTA PPT (White) | Centrifuge and refrigerate. | Collect EDTA plasma according to standard protocol. Separate plasma by centrifugation (at 1,100 RCF for a minimum of 10 minutes) within 24 hours of collection. Plasma must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with CMVQNT, HCQPCR, HIVRNA, HBVDNU, EBVQNT, or BKQUAN. |
Alternate Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 2 mL | Plasma | EDTA (Lavender) | Centrifuge, aliquot and refrigerate ASAP. | Collect EDTA plasma according to standard protocol. Centrifuge (at >1300 RCF for a minimum of 10 minutes) and aliquot into a sterile secondary tube within 24 hours of collection. Plasma must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with CMVQNT, HCQPCR, HIVRNA, HBVDNU, EBVQNT, or BKQUAN. | |
| 2 mL | Serum | SST (Gold) | Centrifuge and refrigerate. | Collect serum according to standard protocol. Separate serum by centrifugation (at 1,100 RCF for a minimum of 10 minutes) within 24 hours of collection. Serum must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with HCQPCR. | |
| 2 mL | Serum | SST (Speckled or Tiger Top) | Centrifuge, aliquot and refrigerate ASAP. | Collect serum according to standard protocol. Centrifuge (at 1,100 RCF for a minimum of 10 minutes) and aliquot into a sterile secondary tube within 24 hours of collection. Serum must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with HCQPCR. | |
| 2 mL | Plasma | Pink KEDTA | Centrifuge and refrigerate. | Collect EDTA plasma according to standard protocol. Centrifuge (at >1300 RCF for a minimum of 10 minutes) and aliquot into a sterile secondary tube within 24 hours of collection. Plasma must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with CMVQNT, HCQPCR, HIVRNA, HBVDNU, EBVQNT, or BKQUAN. |
Minimum Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 1 mL | Minimum volume for testing is 1.0 mL of plasma/serum. Aliquots must be made from specimen prior to testing in any lab outside of Molecular Microbiology, and must be placed in a sterile aliquot tube. |
Stability
| Environmental Condition | Description |
|---|---|
| Ambient | 24 hours for plasma/serum or for whole blood unspun/unseparated |
| Refrigerated | 6 days for plasma/serum separated from whole blood within 24 hours; 24 hours for whole blood unspun/unseparated |
| Frozen | 12 weeks for plasma/serum if separated from whole blood and aliquoted into a secondary tube within 24 hours (plasma/serum cannot be frozen in PPT/SST tubes) |
Days Performed
7 days a week
Turnaround Time
1 - 3 days
Methodology
| Name | Description |
|---|---|
| Polymerase Chain Reaction (PCR), Quant |
Reference Range
| HBV DNA | |||||
|---|---|---|---|---|---|
| Sex | Age From | Age To | Type | Range | Range Unit |
| Normal | Not detected |
Clinical Info
Hepatitis B virus (HBV) is one of several viruses known to cause viral hepatitis. Patients with chronic HBV infection are at high risk of long-term complications of infection, including chronic hepatitis, cirrhosis, and hepatocellular carcinoma. cobas HBV is an FDA-approved in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human EDTA plasma or serum of HBV-infected individuals. This test is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from cobas HBV must be interpreted within the context of all relevant clinical and laboratory findings. The cobas HBV 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. The assay is a quantitative PCR that targets highly conserved regions of HBV and is reported out in international units (IU/mL). The linear range of the assay is 10 to 1,000,000,000 IU/mL (1.00 - 9.00 log IU/mL). The lower limit of detection of the assay is 2.7 IU/mL in EDTA plasma and 2.4 IU/mL in serum.
Clinical Limitation
For full limitations, refer to the assay instructions for use available on the manufacturer's website. The most important limitations are summarized as follows. Though rare, mutations within the highly conserved regions of a viral genome covered by cobas HBV, may affect primers and/or probe binding resulting in the under-quantitation of virus or failure to detect the presence of virus.
Clinical Reference
1. Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. doi: 10.1002/hep.29800. PMID: 29405329. 2. U.S. Food and Drug Administration (FDA). Premarket Approval Summary of Safety and Effectiveness Data P150014. Accessed July 5, 2024. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150014B.pdf.