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Test Directory » Hepatitis C Viral RNA Genotype 1 NS5a Drug Resistance

Hepatitis C Viral RNA Genotype 1 NS5a Drug Resistance

Order Code: HCVGNO

Test Summary

For detection of mutations in the NS5a gene associated with resistance to NS5a inhibitors (examples: daclatasvir, ledipasvir, ombitasvir, elbasvir and velpatasvir). Testing for NS5a resistance-associated variants prior to initiation of treatment with elbasvir plus grazoprevir in HCV genotype 1a infected patients is recommended.

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 collected using heparin as anticoagulant

Order Code

HCVGNO

EPIC (Premier) Code

LAB5838

Includes

HCV NS5a Subtype
Daclatasvir Resistance
Ledipasvir Resistance
Ombitasvir Resistance
Elbasvir Resistance
Velpatasvir Resistance

CPT Code

  • 87902

Billing Code

  • 670036

CPT Statement

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

Monday, Wednesday -Saturday; Report available: 3 - 4 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 collected using heparin as anticoagulant

Billing

CPT Code

  • 87902

Billing Code

  • 670036

CPT Statement

CPT Statement

Result Information

Methodology

Polymerase Chain Reaction (PCR) • Sequencing

Testing Laboratory

N/A

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Monday, Wednesday -Saturday; Report available: 3 - 4 days