FISH, ALL, Pre-B Panel

Message

For Specimen Integrity during Extreme Weather see the “Lockbox Usage in Extreme Weather” document at the top of this page.

Test Code

ALLPRE

CPT Codes
88271 (x9), 88275 (4)

Includes

11q (MLL), 4,10,17, t(9;22), t(12;21)

Preferred Specimen

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

Minimum Volume

1 mL

Other Acceptable Specimens

Whole blood or bone marrow collected in: Sodium heparin (royal blue-top) or sodium heparin lead-free (tan-top) tube

Instructions

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

Submit 1-3 mL of bone marrow or 3-5 mL whole blood in a green-top (sodium heparin) vacutainer tube.
Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.

Transport Temperature

Room temperature

Specimen Stability

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

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

Set up: Sun-Fri; Report available: 7 days

Reference Range

See Laboratory Report

Clinical Significance

Acute lymphoblastic leukemia (ALL) is the most common malignancy diagnosed in children, representing nearly one-third of all pediatric cancers. The annual incidence of ALL is about 30 cases per million people, with a peak incidence in children aged 2-5 years. Various abnormalities have been described and most of them are associated with a determined prognostic outcome. The most common (25% of cases) and most favorable chromosome finding is the hyperdiploid, especially gains of chromosomes 4, 10, and 17. This is followed by the cryptic t(12;21)(p13;q21), TEL/AML1 fusion (22% of cases), also a prognostically favorable marker. Other less frequent but prognostically significant abnormalities include the BCR/ABL t(9;22)(q32;q11.2) and MLL (11q23) rearrangements.

Methodology: Four probe sets, associated with Pre-B cell Acute Lymphoblastic Leukemia, are included in this panel: 11q23 (MLL), 4/10/17 (hyperdiploidy), t(9;22), and t(12;21). 100-300 interphase nuclei are scored for each probe set to detect gain, loss, or rearrangements of the probe regions.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153

Last Updated: November 29, 2021

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.