FISH, Trisomy 12 and 13q Deletion

Test Code

13573

CPT Codes
88271 (x2), 88275

Includes

If results are not possible from the submitted specimen, the test order will be cancelled and replaced by non-orderable test Cytogenetics Communication.

Preferred Specimen

5 mL whole blood or 3 mL bone marrow collected in a sodium heparin (green-top) tube

Minimum Volume

3 mL whole blood • 1 mL bone marrow

Other Acceptable Specimens

Whole blood or bone marrow collected in: sodium heparin (dark blue-top), sodium heparin lead-free (tan-top), or EDTA (lavender-top) tube

Instructions

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

Specimen viability decreases during transit. Send specimen to testing laboratory for viability determination. Do not freeze. Do not reject.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable

Methodology
Fluorescence in situ Hybridization (FISH)

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 available: 5 days

Reference Range

See Laboratory Report

Clinical Significance

The most common prognostically established cytogenetic abnormalities in CLL/SLL are 13q14 deletion, +12, TP53 (17p) deletion and ATM (11q) deletion. Although all these aberrations can be detected using the CLL/SLL FISH panel, trisomy 12 and 13q deletion status can be ordered separately, 13q deletion is associated with a favorable prognosis in CLL/SLL and it is also seen in other lymphoproliferative disorders. Trisomy 12 is strongly associated with CLL/SLL and less frequently with other lymphoproliferative disorders. In CLL/SLL patients, trisomy 12 is often characterized by a lymphocytic proliferation of cells with atypical immunophenotype and lymphocyte morphology and an intermediate prognosis.

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.