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Hepatitis B Virus DNA, Quantitative, PCR with Reflex to HBV, Genotype
Test Code16694
CPT Codes
87517
Includes
If Hepatitis B Virus DNA, Quantitative, Real-Time PCR is ≥600 IU/mL, then Hepatitis B Virus Drug Resistance, Genotype, and BCP/Precore Mutations will be performed at an additional charge (CPT code(s): 87912).
Preferred Specimen
2 mL plasma collected in each of two separate EDTA (lavender-top) tubes
Minimum Volume
1.4 mL in each tube
Other Acceptable Specimens
Serum collected in each of two separate tubes • Plasma collected in each of two separate PPT Potassium EDTA (white top) tubes
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 Temperature
Frozen
Specimen Stability
Room temperature: Unacceptable
Refrigerated: 6 days
Frozen: 30 days
Refrigerated: 6 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Unspun PPT tube • Heparinized samples
Methodology
Real-Time Polymerase Chain Reaction • Sequencing
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
A.M.
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 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).
(1.00 Log IU/mL 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 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).
(1.00 Log IU/mL to 9.00 Log IU/mL).