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 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 (transport)
42 days Frozen
Rejection Criteria:
Gross hemolysis • Grossly lipemic • Specimens collected using heparin as a anticoagulant
Reference Range:
Not Detected
Critical Ranges:
Test Comments:
Methodology:
Polymerase Chain Reaction (PCR) • Sequencing
Clinical Significance:
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.
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
PRODUCTION SCHEDULE
Turn Around Time:
2 to 4 days
Days Performed:
Sunday, Monday, Tuesday, Wednesday, Thursday, Friday, Saturday
PHL Test Code:
HCV5A
EPIC Test Code:
LAB3008
Send Out Test Code:
92447
Alternate Test Names:
HCV Genotype 1 NS5a; HCV Gentotype 1 NS5A
Included Tests:
HCV NS5a Subtype; Daclatasvir Resistance; Ledipasvir Resistance; Ombitasvir Resistance
CPT Coding:
87902