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

Test Code

10106

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

Sodium heparin (royal blue-top) tube • Sodium heparin lead-free (tan-top) tube

Instructions

Bone marrow 1-3 mL, or whole blood 3-5 mL, sodium heparin only

Transport Temperature

Room temperature

Specimen Stability

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

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: 5-7 days

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.

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.