ABL T315I Mutation in CML, Cell-based

Test Code
19783

CPT Codes
81401

Preferred Specimen
6 mL whole blood collected in an EDTA (lavender-top) tube

Minimum Volume
4 mL whole blood • 1 mL bone marrow

Other Acceptable Specimens
3 mL bone marrow collected in an EDTA (lavender-top) tube

Instructions
Preferred sample type is whole blood. Bone marrow is acceptable.

Collect 6 mL of whole blood or 3 mL bone marrow in lavender-top (EDTA) tube. Whole blood or bone marrow is shipped refrigerated. Do not freeze whole blood or bone marrow. After collection of the sample, draw date and time, as well as sample type, must be written on the tube and included as requested information. Ship sample immediately due to short stability of 72 hours. If the stability of the sample cannot be determined, delay in result or cancellation of test may occur.

Stability restrictions: Whole blood samples must be received in Chantilly Monday through Friday a.m. within 24 hours of collection.

Note:
Specimen is stabilized upon receipt at Nichols Institute, San Juan Capistrano.


Transport Temperature
Room temperature

Specimen Stability
Room temperature: 72 hours
Refrigerated: 72 hours
Frozen: Unacceptable

Methodology
Fragment Analysis • Polymerase Chain Reaction (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: Tues, Sat; Report available: 4 days

Reference Range
Negative

Clinical Significance
Mutations in the kinase domain of Bcr-abl are the leading cause of acquired imatinib resistance. Although mutations have been identified in more than 30 different amino acids, the highest degree of resistance was associated with single-point mutation T315I of the abl gene in the Bcr-abl fusion transcript. Early detection of T315I mutation of CML patient in therapy or pre-therapy could allow alternative treatment before resistance is detected cytogenetically or before disease progression become evident.

Performing Laboratory
Quest Diagnostics Nichols Inst San Juan Capistrano
33608 Ortega Highway
San Juan Capistrano, CA 92690-6130



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.