FISH, RUNX1T1/RUNX1 (ETO/AML1), Translocation (8;21)
Order Code:
AML821
Test Summary
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.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
5 mL whole blood 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/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".
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".
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: See Collection Instructions
- Refrigerated: See Collection Instructions
- Frozen: See Collection Instructions
Limitations
N/A
Other Acceptable Specimens
Whole blood or Bone marrow collected in: sodium heparin (royal blue-top) tube, or sodium heparin lead-free (tan-top) tube
Unacceptable Specimens
N/A
Order Code
AML821
EPIC (Premier) Code
LAB3005
Includes
N/A
CPT Code
- 88271 (x2)
- 88275
Billing Code
- 670940: 670941
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
14225 Newbrook Drive
Chantilly VA, 20153
Department
Reference Testing
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Daily; Report available: 5 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
5 mL whole blood 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/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".
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".
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: See Collection Instructions
- Refrigerated: See Collection Instructions
- Frozen: See Collection Instructions
Limitations
N/A
Other Acceptable Specimens
Whole blood or Bone marrow collected in: sodium heparin (royal blue-top) tube, or sodium heparin lead-free (tan-top) tube
Unacceptable Specimens
N/A
Result Information
Methodology
Fluorescence In Situ Hybridization (FISH)
Testing Laboratory
N/A
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Daily; Report available: 5 days