Hepatitis C Viral RNA Genotype 1 NS5a Drug Resistance
Test Summary
For detection of mutations in the NS5a gene associated with resistance to NS5a inhibitors (examples: daclatasvir, ledipasvir, ombitasvir, elbasvir and velpatasvir). Testing for NS5a resistance-associated variants prior to initiation of treatment with elbasvir plus grazoprevir in HCV genotype 1a infected patients is recommended.
Aliases
- N/A
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 plasma from whole blood within 24 hours of collection by centrifugation. Transfer to a transport tube and refrigerate or freeze.
Serum is collected in a serum separator tube (SST) or red-top tube (no gel). Transfer to a transport tube and refrigerate or freeze.
Serum is collected in a serum separator tube (SST) or red-top tube (no gel). Transfer to a transport tube and refrigerate or freeze.
Patient Preparation
N/A
Storage
Transport tube
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
- Room temperature: 72 hours
- Refrigerated: 14 days
- 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 collected using heparin as anticoagulant
Order Code
HCVGNO
EPIC (Premier) Code
LAB5838
Includes
HCV NS5a Subtype
Daclatasvir Resistance
Ledipasvir Resistance
Ombitasvir Resistance
Elbasvir Resistance
Velpatasvir Resistance
Daclatasvir Resistance
Ledipasvir Resistance
Ombitasvir Resistance
Elbasvir Resistance
Velpatasvir Resistance
CPT Code
- 87902
Billing Code
- 670036
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, Wednesday -Saturday; Report available: 3 - 4 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 plasma from whole blood within 24 hours of collection by centrifugation. Transfer to a transport tube and refrigerate or freeze.
Serum is collected in a serum separator tube (SST) or red-top tube (no gel). Transfer to a transport tube and refrigerate or freeze.
Serum is collected in a serum separator tube (SST) or red-top tube (no gel). Transfer to a transport tube and refrigerate or freeze.
Patient Preparation
N/A
Storage
Transport tube
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
- Room temperature: 72 hours
- Refrigerated: 14 days
- 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 collected using heparin as anticoagulant
Result Information
Methodology
Polymerase Chain Reaction (PCR) • Sequencing
Testing Laboratory
N/A
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Monday, Wednesday -Saturday; Report available: 3 - 4 days