FISH, CLL, CEP 12, Trisomy 12

Test Code

16668

CPT Codes
88271, 88275

Preferred Specimen

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

Minimum Volume

1 mL bone marrow • 3 mL whole blood

Other Acceptable Specimens

Bone marrow or whole blood collected in: sodium heparin (royal blue-top) tube, or sodium heparin lead-free (tan-top) tube • 5x5mm fresh lymph node collected in culture transport medium

Instructions

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

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

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

Transport Temperature

Room temperature

Specimen Stability

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

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

Received frozen

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 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

Monday-Sunday Morning Report available: 5 Days

Reference Range

See Laboratory Report

Clinical Significance

This test is performed in addition to routine chromosome analysis. FISH (fluorescence in situ hybridization) analysis is performed on 100 or more interphase nuclei from peripheral blood, bone marrow or lymph node to identify and enumerate chromosome 12 using a DNA probe specific for the centromeric region. Trisomy 12 is one of the most commonly reported chromosome aberrations in B-cell chronic lymphocytic leukemia (CLL) and is of prognostic importance. FISH analysis detects trisomy 12 in non-dividing cells which cannot be identified with routine cytogenetic studies.

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.