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| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
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 ≥300 IU/mL, then Hepatitis C Viral RNA, Genotype, LiPA will be performed at an additional charge (CPT code(s) 87902).
If Hepatitis C Viral Genotype, LiPA 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, LiPA 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
Freshly drawn specimens (whole blood) may be stored at 2-25° C for up to 24 hours prior to centrifugation.
Separate plasma or serum from cells within 24 hours of collection by centrifugation. Follow manufacturer's instructions for collection tube handling.
Separate plasma or serum from cells within 24 hours of collection by centrifugation. Follow manufacturer's instructions for collection tube handling.
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: 72 hours
Refrigerated: 14 days
Frozen: 42 days
Refrigerated: 14 days
Frozen: 42 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Whole blood samples >24 hours • Frozen whole blood
Methodology
DNA Sequencing • Multi-Probe Reverse Hybridization • Polymerase Chain Reaction (PCR) • Real-Time Polymerase Chain Reaction
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: Mon-Sat; Report available: 6 days
Reference Range
| HCV RNA, QN, Real-Time PCR | Not detected | IU/mL |
| HCV RNA, QN, Real-Time PCR | Not detected | LogIUm/ML |
| Hepatitis C Viral RNA, Genotype, LiPA | Not detected |
| HCV NS5a Subtype | Not detected |
| Daclatasvir Resistance | Not detected |
| Daclatasvir Resistance | Not detected |
| Ombitasvir Resistance | Not detected |
| Elbasvir Resistance | Not detected |
Clinical Significance
Hepatitis C (HCV) viral genotype is required prior to the initiation of antiviral therapy with direct acting agents. In addition, the FDA package insert recommends baseline NS5a resistance testing for HCV genotype 1a patients being evaluated for treatment with Zepatier™, which contains the NS5a inhibitor elbasvir and the NS3 protease inhibitor grazoprevir.
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 with Zepatier™ or in other circumstances where all three tests are warranted.
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 with Zepatier™ or in other circumstances where all three tests are warranted.
