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FISH, APL, PML/RARA, Translocation 15,17, Technical Component
Test Code37878
CPT Codes
88271 (x2), 88275<br>Restricted Client Code - Tech Code
Preferred Specimen
5 mL whole blood or 3 mL bone marrow collected in a sodium heparin (green-top) tube
Minimum Volume
3 mL whole blood • 1 mL bone marrow
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
If results are not possible, the test order may be canceled and replaced with a Cytogenetics Communication.
Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.
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
Refrigerated: See instructions
Frozen: See instructions
Methodology
Fluorescence in situ Hybridization
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 assay for PML-RARA rearrangements such as t(15;17) is useful for diagnosis, prognosis and monitoring of acute promyelocytic leukemia.
Methodology: FISH (fluorescence in situ hybridization) is performed to detect PML-RARA fusions and rearrangements. 200 interphase nuclei are scored for the probe set and are provided to the client for the purpose of determining rearrangements, gains, and/or losses of the probe region.
Methodology: FISH (fluorescence in situ hybridization) is performed to detect PML-RARA fusions and rearrangements. 200 interphase nuclei are scored for the probe set and are provided to the client for the purpose of determining rearrangements, gains, and/or losses of the probe region.