Hepatitis C Viral RNA Genotype 1 NS5b Drug Resistance

Last Modified: 5/9/2016 3:06:08 PM

Specimen Requirements: 2.0 mL Plasma from a Lavender Top Tube - EDTA in a plastic vial
Collection Instructions: Separate plasma from whole blood within 24 hours of collection by centrifugation. Transfer to a plastic, screw-cap vial and refrigerate or freeze
Minimum Volume: 0.6 mL Plasma
Transport & Storage: Temperature/Stability: 72 hours Ambient
14 days Refrigerated
42 days Frozen
Rejection Criteria: Gross hemolysis • Gross lipemia • Specimens collected using heparin as anticoagulant
Reference Range:
HCV NS5b Subtype Not detected
Methodology: Polymerase Chain Reaction (PCR) • Sequencing
Clinical Significance: For detection of mutations in the Genotype 1 NS5b gene associated with resistance to nucleotide analog NS5b polymerase inhibitors (example: sofosbuvir, a nucleotide analog inhibitor of HCV NS5b polymerase).
Documentation: This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Custom Panel: No


Turn Around Time: 6 to 11 days
Days Performed: Tuesday
PHL Test Code: MSOT
EPIC Test Code:
Send Out Test Code: 92204
Included Tests: HCV NS5b Subtype, Sofosbuvir Resistance
CPT Coding: 87902

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