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Acute Myeloid Leukemia Prognostic Panel (Normal Karyotype)
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Test Code
AMLPP
CPT Codes
81218, 81310, 81245, 81246
Includes
CEBPA Mutation Analysis
NPM (Exon 12) Mutation Analysis, Cell-based
FLT3 Mutation Assay
NPM (Exon 12) Mutation Analysis, Cell-based
FLT3 Mutation Assay
Preferred Specimen
5 mL whole blood collected in an EDTA (lavender-top) tube
Minimum Volume
3 mL whole blood
Other Acceptable Specimens
3 mL (1 mL minimum) bone marrow collected in an EDTA (lavender-top) tube
Cell pellet collected in a sterile transport tube
5x5 mm (2x3 mm minimum)t issue collected in a paraffin block
Cell pellet collected in a sterile transport tube
5x5 mm (2x3 mm minimum)t issue collected in a paraffin block
Instructions
Do Not Reject.
Send to lab for evaluation. Submission of whole blood (preferred): Follow standard whole blood collection procedure. Collect 3-5 mL whole blood samples in EDTA tube. Blood samples are shipped at room temperature or 4 degrees C. Do not freeze whole blood. Record the draw time and date on the tube. Ship immediately to maintain sample stability.
Cell Pellet Instructions: This assay is also designed for the remnant cell pellet from Cytogenetics. The cell pellet usually fixed should be transported refrigerated to the laboratory as soon as possible. Please provide a copy of the Cytogenetics report.
Send to lab for evaluation. Submission of whole blood (preferred): Follow standard whole blood collection procedure. Collect 3-5 mL whole blood samples in EDTA tube. Blood samples are shipped at room temperature or 4 degrees C. Do not freeze whole blood. Record the draw time and date on the tube. Ship immediately to maintain sample stability.
Cell Pellet Instructions: This assay is also designed for the remnant cell pellet from Cytogenetics. The cell pellet usually fixed should be transported refrigerated to the laboratory as soon as possible. Please provide a copy of the Cytogenetics report.
Transport Temperature
Whole blood, bone marrow, tissue: Room temperature
Cell pellet: Refrigerated (cold packs)
Cell pellet: Refrigerated (cold packs)
Specimen Stability
Whole Blood / Bone Marrow
Room Temperature = 7 days
Refrigerated = 7 days
Frozen = Unacceptable
Cell Pellet
Room Temperature = Unacceptable
Refrigerated = 30 days
Frozen = 30 days
Tissue
Room Temperature = Preferred
Refrigerated = Acceptable
Frozen = Unacceptable
Room Temperature = 7 days
Refrigerated = 7 days
Frozen = Unacceptable
Cell Pellet
Room Temperature = Unacceptable
Refrigerated = 30 days
Frozen = 30 days
Tissue
Room Temperature = Preferred
Refrigerated = Acceptable
Frozen = Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Do not reject
Methodology
See individual tests
FDA Status
CEBPA Mutation Analysis and NPM (Exon 12) Mutation Analysis, Cell-based: 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 and Report available: See individual assays
Reference Range
See Laboratory Report
Clinical Significance
This testing, consisting of FLT3, NPM-1, and CEBPA, is recommended in the NCCN guidelines for determination of AML risk status in patients with cytogenetically normal AML. The presence of CEBPA gene mutations is associated with increased disease-free survival and overall survival. Mutations in NPM1 gene is a predictor of favorable prognosis and good response to induction chemotherapy. The presence of (FLT3) internal tandem duplication is associated with short disease-free survival.
Performing Laboratory
| Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
| 33608 Ortega Highway |
| San Juan Capistrano, CA 92675-2042 |
Last Updated: November 24, 2021
