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AccuType® IL28B
Test Code90251
CPT Codes
81283<br /> For New York patient testing, use test code 90252
Physician Attestation of Informed Consent
This germline genetic test requires physician attestation that patient consent has been received if ordering medical facility is located in AK, DE, FL, GA, IA, MA, MN, NV, NJ, NY, OR, SD or VT or test is performed in MA.
Preferred Specimen
5 mL whole blood collected in an EDTA (lavender-top) tube
Patient Preparation
Do not eat immediately prior to sample collection. If patient has eaten recently, rinse mouth with plain water.
Minimum Volume
2 mL
Other Acceptable Specimens
Whole blood collected in: ACD solution A (yellow-top) tube or ACD solution B (yellow-top) tube
Buccal swab collected in: DNA Genotek Oracollect Kit or Celera DNA Collection Kit (follow collection kit instructions)
Buccal swab collected in: DNA Genotek Oracollect Kit or Celera DNA Collection Kit (follow collection kit instructions)
Instructions
Transport: Whole blood is shipped ambient (18-26°C). Do not freeze whole blood.
Stability: Whole blood: 8 days at ambient temperature (18-26 °C) or 8 days refrigerated (2-10 °C). Do not freeze whole blood.
Use only Celera/Copan DNA collection kit (Celera part # is 5002737) or DNA Genotek OraCollect kit (OC-100). Follow collection kit instructions.
Stability: Whole blood: 8 days at ambient temperature (18-26 °C) or 8 days refrigerated (2-10 °C). Do not freeze whole blood.
Use only Celera/Copan DNA collection kit (Celera part # is 5002737) or DNA Genotek OraCollect kit (OC-100). Follow collection kit instructions.
Transport Temperature
Room temperature
Specimen Stability
Whole blood
Room temperature: 8 days
Refrigerated: 8 days
Frozen: Unacceptable
Buccal swab
Room temperature: 14 days
Refrigerated: Unacceptable
Frozen: Unacceptable
Room temperature: 8 days
Refrigerated: 8 days
Frozen: Unacceptable
Buccal swab
Room temperature: 14 days
Refrigerated: Unacceptable
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Incorrect collection device • Liquid has leaked from container/no liquid present
Methodology
Real-Time Polymerase Chain Reaction
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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
This test is performed pursuant to a license agreement with Roche Diagnostics, Inc.
Setup Schedule
Night
Report Available
Reports in 2 to 4 days
Clinical Significance
The C polymorphism in rs12979860 is strongly associated with a two fold greater sustained virological response in European, African American, and Hispanic populations. Knowledge of the host genotype of patients infected with HCV will aid in the clinical decision to initiate treatment with PegIFN and RBV (a 48 week course of interferon and ribavirin which has limited efficacy and is often poorly tolerated due to side effects that prevent patients from finishing treatment).
