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CLL Profile
Test Code36921
CPT Codes
81450, 88271 (x11), 88275 (x5)<br>This test is not available for New York patient testing
Includes
Trisomy 12, 13q deletion, TP53 (17p13) deletion, ATM (11q22.3) deletion, 6q deletion, IGH (14q32.3) rearrangement, IGH/CCND1 t(11;14) translocation, reflex to IGH/BCL2 t(14;18) translocation probe will be performed at an additional charge (CPT code(s): 88271 (x2), 88275).
Preferred Specimen
10 mL peripheral blood collected in an EDTA (lavender-top), or sodium heparin (green-top) tube
Minimum Volume
5 mL peripheral blood • 2 mL bone marrow
Other Acceptable Specimens
3 mL bone marrow collected in EDTA (lavender-top) tube, or sodium heparin (green-top) tube
Instructions
Do not centrifuge
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: 48 hours
Refrigerated: 15 days
Frozen: Unacceptable
Refrigerated: 15 days
Frozen: Unacceptable
Methodology
Next Generation Sequencing • Fluorescence in situ hybridization (FISH)
FDA Status
This test was developed and its performance characteristics determined by med fusion. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.
Setup Schedule
Monday, Thursday Morning
Report available: 8 Days
Report available: 8 Days
Reference Range
See Laboratory Report
Clinical Significance
Helps physicians diagnose and predict the course of disease progression for hematologic diseases.
