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Hepatitis C Viral RNA Genotype 3 NS5a Drug Resistance

Test Summary

For detection of mutations in the genotype 3 NS5a gene associated with resistance to NS5a inhibitors (example: daclatasvir, velpatasvir) including the Y93H polymorphism.

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.

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 using heparin as the anticoagulant

Order Code

HCVGN3

EPIC (Premier) Code

LAB5839

Includes

HCV NS5a Subtype, Daclatasvir Resistance, Velpatasvir Resistance

CPT Code

  • 87902

Billing Code

  • 670035

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

Department

Reference Testing

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Tuesday; Report available: 4 - 11 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.

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 using heparin as the anticoagulant

Billing

CPT Code

  • 87902

Billing Code

  • 670035

CPT Statement

Result Information

Methodology

Polymerase Chain Reaction (PCR) • Sequencing

Testing Laboratory

N/A

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Tuesday; Report available: 4 - 11 days