FISH, CML/ALL, bcr/abl t(9,22), Technical Component

Test Code

37875

CPT Codes
88271 (x2), 88275<br /> Tech Only Code

Includes

If results are not possible, the test order may be canceled and replaced by a Cytogenetics Communication.

Preferred Specimen

3 mL bone marrow in transport media

Minimum Volume

1 mL bone marrow • 2-3 mL whole blood

Other Acceptable Specimens

3 mL bone marrow collected in: sodium heparin (green-top) tube, sodium heparin (royal blue-top) tube, or sodium heparin lead-free (tan-top) tube • 3-5 mL whole blood collected in: sodium heparin (green-top) tube, sodium heparin (royal blue-top) tube, or sodium heparin lead-free (tan-top) tube

Instructions

Clinical history/reason for referral is required with test order. Prior therapy and bone marrow transplant history should be provided with test order.

Bone marrow (preferred) 1-3 mL, or whole blood 3-5 mL. Green vacutainer (sodium heparin only). Royal blue or tan top sodium heparin tubes are acceptable containers for this test. Ship at room temperature. Bone marrow transport medium is available upon request.

Specimen viability decreases during transit. Send specimen to testing lab for viability. Do not reject.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: See instructions
Refrigerated: See instructions
Frozen: Unacceptable

Methodology
Fluorescence in situ Hybridization

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 the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Daily; Report available: 5 days

Reference Range

See Laboratory Report

Clinical Significance

This test is performed to detect the molecular rearrangement of the BCR and ABL1 genes involved in translocation t(9;22) associated with chronic myelogenous leukemia (CML), acute lymphocytic leukemia (ALL) and acute myeloid leukemia (AML) using FISH (fluorescence in situ hybridization). This test may be used in the evaluation of Ph negative CML, complex rearrangements or for followup to therapy for previously diagnosed Ph+ patients.

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.