AccuType® Ribavirin (ITPA)

Test Code

91416

CPT Codes
81479

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.

Includes

rs1127354 genotype, rs7270101 genotype

Preferred Specimen

4 mL whole blood collected in an EDTA (lavender-top) tube

Minimum Volume

2 mL

Other Acceptable Specimens

Whole blood collected in: ACD solution A (yellow-top) tube, ACD solution B (yellow-top) tube, Sodium heparin (green-top) tube or Lithium heparin (green-top) tube

Instructions

Normal phlebotomy procedure. Store and ship room temperature immediately. Do not freeze.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 8 days
Refrigerated: 8 days
Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Received frozen

Methodology
Real-Time Polymerase Chain Reaction (RT-PCR)

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.

Setup Schedule

Set up: Daily; Report Aavailable: 3-4 days

Clinical Significance

A laboratory developed, duplex real-time PCR assay on ABI's ViiA7 instrument detects SNPs rs1127354 and rs7270101 in the inosine triphosphatase (ITPA) gene for patients being treated for hepatitis C virus (HCV) to help assess risk of ribavirin (RBV) induced anemia.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.