Hepatitis C Viral RNA, Genotype, LIPA
Order Code: HCVRGE
Test Summary
Determination of hepatitis C genotype is often required to select the most appropriate direct acting agent(s) (DAA) for the treatment of hepatitis C. Some DAA's are only effective for the treatment of hepatitis C genotype 1, whereas others may be used for additional genotypes. Refer to the package inserts of the relevant DAA's for guidance. A concurrent patient HCV viral load of >=300 IU/mL is required for this test.
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 or serum 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 refrigerated or frozen.
Patient Preparation
N/A
Storage
Plastic screw-cap vial
Transport Temperature
Refrigerated
Specimen Stability
- Room temperature: 72 hours, Refrigerated: 14 days, Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
Plasma collected in: a PPT potassium EDTA (white-top) tube • Serum
Unacceptable Specimens
Gross hemolysis • Grossly lipemic • Unspun PPT tube • Specimens collected using heparin as anticoagulant • Unspun serum separator tube (SST) • Unspun red-top tube (no gel) • Received room temperature
Order Code
HCVRGE
EPIC (Premier) Code
LAB6903
Includes
N/A
CPT Code
- 87902
Billing Code
- 670069
CPT Statement
Methodology
Real-Time Polymerase Chain Reaction • 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.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153
14225 Newbrook Drive
Chantilly VA, 20153
Department
Reference Testing
Reference Range
Not Detected
Setup Schedule / Expected Turnaround Time
Daily; Report available: 2 - 5 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 or serum 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 refrigerated or frozen.
Patient Preparation
N/A
Storage
Plastic screw-cap vial
Transport Temperature
Refrigerated
Specimen Stability
- Room temperature: 72 hours, Refrigerated: 14 days, Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
Plasma collected in: a PPT potassium EDTA (white-top) tube • Serum
Unacceptable Specimens
Gross hemolysis • Grossly lipemic • Unspun PPT tube • Specimens collected using heparin as anticoagulant • Unspun serum separator tube (SST) • Unspun red-top tube (no gel) • Received room temperature
Result Information
Methodology
Real-Time Polymerase Chain Reaction • Sequencing
Testing Laboratory
N/A
Reference Range
Not Detected
Setup Schedule / Expected Turnaround Time
Daily; Report available: 2 - 5 days