Hepatitis C Viral RNA, Quantitative Real-Time PCR with Reflexes

Test Code

93873

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).

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.

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: 72 hours
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: 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 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.

Performing Laboratory

Quest Diagnostics Nichols Institute-San Juan Capistrano, CA

33608 Ortega Highway

San Juan Capistrano, CA 92675-2042

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.