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Hepatitis C Viral RNA Genotype 1 NS3 Drug Resistance
Test Code90924
CPT Codes
87902
Preferred Specimen
2 mL plasma collected in an EDTA (lavender-top) tube
Minimum Volume
0.6 mL
Other Acceptable Specimens
Plasma collected in: PPT potassium EDTA (white-top) tube • Serum
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.
Transport Container
Polypropylene screw-cap vial
Transport Temperature
Frozen
Specimen Stability
Room temperature: Unacceptable
Refrigerated: 72 hours
Frozen: 42 days
Refrigerated: 72 hours
Frozen: 42 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Grossly lipemic • Specimens using heparin as the anticoagulant
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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Mon; Report available: 4-11 days
Reference Range
See Laboratory Report
Clinical Significance
This assay may be used to detect grazoprevir, simeprevir and paritaprevir resistance-associated NS3 mutations in genotype 1 NS3 protease inhibitor treatment-experienced patients and also the Q80K polymorphism in patients being considered for a simeprevir-containing regimen.
Performing Laboratory
| Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
| 33608 Ortega Highway |
| San Juan Capistrano, CA 92675-2042 |
