Hepatitis C Viral RNA Genotype 1 NS3 Drug Resistance

Last Modified: 3/27/2019 3:02:40 PM


Medical Necessity Documentation:  
Client Notes:  
Patient Preparation:  
Specimen Requirements: 2.0 mL Plasma from a Lavender Top Tube - EDTA in a Plastic Vial
Collection Instructions: Separate plasma (preferred) from whole blood within 24 hours of collection by centrifugation at 800-1600 x g for 20 minutes at room temperature.
 Transfer the plasma to a properly identified, sterile, polyproprylene screw-cap vial and ship refrigerated or frozen.
Please note: HCV genotype 1 is required for this test.
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 using heparin as the anticoagulant
Reference Range: Refer to Interpretive Results
Critical Ranges:  
Test Comments:  
Methodology: Polymerase chain reaction (PCR) • Sequencing
Clinical Significance: This assay may be used to detect grazoprevir, simeprevir and paritaprevir resistance-associated NS3 mutations in genotype 1 NS3 protease inhibitor treatment-experienced patients and also the Q80K polymorphism in patients being considered for a simeprevir-containing regimen.
Documentation:  
Custom Panel: No

PRODUCTION SCHEDULE

Turn Around Time: 4 to 11 days
Days Performed: Monday
PHL Test Code: HCN53
EPIC Test Code: LAB3007
Send Out Test Code: 90924
Alternate Test Names: Boceprevir Resistance; HCV NS3; NS3 Protease Mutations; NS3 Subtype,HCV; Q80K Polymorphism; Simeprevir Resistance; Telaprevir Resistance
Included Tests:  
CPT Coding: 87903

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