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Hepatitis B Virus DNA, Quantitative, Real-Time PCR : 8369
Test CodeHBVQNT or 8369
CPT Codes
87517
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 from cells within 24 hours of collection by centrifugation. Follow manufacturer’s instructions for collection tube handling.
Primary tubes or aliquots from primary tubes preferred; specimen sharing is not recommended.
Primary tubes or aliquots from primary tubes preferred; specimen sharing is not recommended.
Transport Container
Preferred Specimen:
3 mL plasma collected and separated from an EDTA (lavender-top) tube
Alternative Specimens:
Plasma collected in PPT potassium EDTA (white-top) tube; Serum
Minimum Volume: 1 mL
3 mL plasma collected and separated from an EDTA (lavender-top) tube
Alternative Specimens:
Plasma collected in PPT potassium EDTA (white-top) tube; Serum
Minimum Volume: 1 mL
Transport Temperature
Frozen.
Specimen Stability
Room temperature: Unacceptable; 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
Setup Schedule
Monday & Thursday
Report Available
1-4 days
Limitations
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.
Reference Range
Reportable Range: 10 to 1,000,000,000 IU/mL or 1.00 to 9.00 log IU/mL
Reference range:
Not Detected IU/mL
Not Detected log IU/mL
Reference range:
Not Detected IU/mL
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.
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.
Performing Laboratory
med fusion
