FISH, RUNX1T1/RUNX1 (ETO/AML1), Translocation (8;21)

Message

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

Test Code

AML821

CPT Codes
88271 (x2), 88275

Preferred Specimen

5 mL whole blood 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) tube, or sodium heparin lead-free (tan-top) tube

Instructions

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

Specimen requirements: 3-5 mL whole blood or 1-3 mL bone marrow collected in a sodium heparin tube

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

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

Transport Temperature

Room temperature

Specimen Stability

Room temperature: See Collection Instructions
Refrigerated: See Collection Instructions
Frozen: See Collection 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: Daily; Report available: 5 days

Reference Range

See Laboratory Report

Clinical Significance

This test is performed to detect the RUNX1T1 (ETO;8q22) and RUNX1 (AML1;21q22), translocation t(8;21), by FISH (fluorescence in situ hybridization). This assay is useful for diagnosis of acute myeloid leukemia (AML) with RUNX1T1/RUNX1 (ETO/AML1) gene fusion.

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.