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Hepatitis C Viral RNA, Quantitative Real-Time PCR with Reflexes
Test Code93873
CPT Codes
87522
Includes
If Hepatitis C Viral RNA, Quantitative Real-Time PCR is ≥2000 IU/mL, then Hepatitis C Virus RNA, Genotype will be performed at an additional charge (CPT code(s) 87902).
If Hepatitis C Viral Genotype is GENOTYPE 1 or GENOTYPE 1a, then Hepatitis C Viral RNA Genotype 1 NS5a Drug Resistance will be performed at additional charge (CPT code(s): 87902).
If Hepatitis C Viral Genotype is GENOTYPE 1 or GENOTYPE 1a, then Hepatitis C Viral RNA Genotype 1 NS5a Drug Resistance will be performed at additional charge (CPT code(s): 87902).
Preferred Specimen
3 mL plasma collected in an EDTA (lavender-top) tube
Minimum Volume
1.8 mL
Other Acceptable Specimens
Plasma collected in: PPT potassium EDTA (white-top) tube • Serum
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 or red-top tube (no gel). Transfer to a transport tube and refrigerate or freeze.
Transport Container
Transport tube
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: 72 hours
Refrigerated: 14 days
Frozen: 30 days
Refrigerated: 14 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Grossly lipemic • Specimens collected using heparin as anticoagulant • Frozen whole blood
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
Set up: Daily; Report available: 7 days
Reference Range
| HCV RNA, QN, Real-Time PCR | Not detected (IU/mL) |
| HCV RNA, QN, Real-Time PCR | Not detected (Log IU/mL) |
Clinical Significance
Hepatitis C (HCV) viral genotype may be required to select the most appropriate direct acting agent(s) (DAA) in the treatment of hepatitis C. Refer to the FDA package inserts of the relevant DAA's and to the AASLD and IDSA Recommendations for Testing, Managing and Treating Hepatitis C (https://www.hcvguidelines.org/). This reflex code offers clinicians the option to obtain the HCV Viral load, HCV genotype and NS5a resistance testing with a single test order when considering treatment in circumstances where all three tests are warranted.
Performing Laboratory
| Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
| 33608 Ortega Highway |
| San Juan Capistrano, CA 92675-2042 |
Last Updated: May 19, 2016
