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Test Directory FISH, ALL, Pre-B Panel

FISH, ALL, Pre-B Panel

Order Code: ALLPRE

Test Summary

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.

Aliases

Specimen Collection

Special Instructions

N/A

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

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.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

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

Limitations

N/A

Other Acceptable Specimens

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

Unacceptable Specimens

N/A

Order Code

ALLPRE

EPIC (Premier) Code

LAB6335

Includes

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

CPT Code

88271 (9), 88275 (4)

Billing Code

670538
670539

CPT Statement

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. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153

Department

Reference Testing

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Sunday - Friday; Report available: 7 days