A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
Hepatitis B Virus DNA, Quantitative, Real-Time PCR
Test Code8369
Alias/See Also
LAB1337
CPT Codes
87517
Preferred Specimen
3 mL plasma collected and separated from an EDTA (lavender-top) tube
Minimum Volume
1 mL
Other Acceptable Specimens
Serum • PPT potassium EDTA (white-top) tube
Instructions
Do not freeze whole blood or any samples stored in primary tube. 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. Follow manufacturer’s instructions for collection tube handling.
Transport Container
Transport tube
Transport Temperature
Frozen
Specimen Stability
Room temperature: Unacceptable
Refrigerated: 6 days
Frozen: 84 days
Refrigerated: 6 days
Frozen: 84 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Unspun whole blood sample >24 hours from collection
Methodology
Real-Time Polymerase Chain Reaction
FDA Status
The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Sun-fri
Report Available
3-5 days
Limitations
Results obtained from immunosuppressed patients should be interpreted with caution.
Reference Range
Hepatitis B Virus DNA | Not Detected (IU/mL) |
Hepatitis B Virus DNA | Not Detected (Log IU/mL) |
Clinical Significance
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.
Reportable range is 10 to 1,000,000,000 IU/mL (1.00 to 9.00 Log IU/mL).
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.
Reportable range is 10 to 1,000,000,000 IU/mL (1.00 to 9.00 Log IU/mL).
Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
33608 Ortega Highway |
San Juan Capistrano, CA 92675-2042 |