Hepatitis C Viral RNA Genotype 1 NS3 Drug Resistance
Order Code:
HCVRES
Test Summary
This assay may be used to detect boceprevir, simeprevir and partaprevir resistance-associated NS3 mutations in NS3 protease inhibitor treatment-experienced patients and also the Q80K polymorphism in patients being considered for a simeprevir-containing regimen.
Aliases
- Boceprevir Resistance * HCV* NS3 Protease Mutations* NS3 Subtype * Q80K Polymorphism * Simeprevir Resistance* Partiaprevir Resistance
Specimen Collection
Special Instructions
N/A
Preferred Specimen
2 mL plasma collected in an EDTA (lavender-top) tube
Minimum Volume
0.6 mL
Instructions
Separate serum or plasma from whole blood within 24 hours of collection by centrifugation at 800-1600 x g for 20 minutes at room temperature. Transfer the plasma to a properly identified, sterile, polypropylene screw-cap vial and ship frozen.
Please note: HCV genotype 1 is required for this test.
Please note: HCV genotype 1 is required for this test.
Patient Preparation
N/A
Storage
Polypropylene screw-cap vial
Transport Temperature
Frozen
Specimen Stability
- Room temperature: Unacceptable
- Refrigerated: 72 hours
- Frozen: 42 days
Limitations
N/A
Other Acceptable Specimens
Plasma collected in: PPT potassium EDTA (white-top) tube • Serum
Unacceptable Specimens
Gross hemolysis • Grossly lipemic • Specimens using heparin as the anticoagulant
Order Code
HCVRES
EPIC (Premier) Code
LAB5668
Includes
N/A
CPT Code
- 87902
Billing Code
- 670037
CPT Statement
Methodology
Polymerase Chain Reaction (PCR) • Sequencing
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675
33608 Ortega Highway
San Juan Capistrano CA, 92675
Department
Reference Testing
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Monday; Report available: 4 - 11 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
2 mL plasma collected in an EDTA (lavender-top) tube
Minimum Volume
0.6 mL
Instructions
Separate serum or plasma from whole blood within 24 hours of collection by centrifugation at 800-1600 x g for 20 minutes at room temperature. Transfer the plasma to a properly identified, sterile, polypropylene screw-cap vial and ship frozen.
Please note: HCV genotype 1 is required for this test.
Please note: HCV genotype 1 is required for this test.
Patient Preparation
N/A
Storage
Polypropylene screw-cap vial
Transport Temperature
Frozen
Specimen Stability
- Room temperature: Unacceptable
- Refrigerated: 72 hours
- Frozen: 42 days
Limitations
N/A
Other Acceptable Specimens
Plasma collected in: PPT potassium EDTA (white-top) tube • Serum
Unacceptable Specimens
Gross hemolysis • Grossly lipemic • Specimens using heparin as the anticoagulant
Result Information
Methodology
Polymerase Chain Reaction (PCR) • Sequencing
Testing Laboratory
N/A
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Monday; Report available: 4 - 11 days