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DLBCL Profile
Test Code37171
CPT Codes
81450, 88271 (x8), 88275 (x4) <br><strong>This test is not available for New York patient testing.</strong>
Preferred Specimen
10 mL peripheral blood or 3 mL bone marrow collected in an EDTA (lavender-top) or a sodium heparin (green-top) tube or
Fresh tissue (1 cm3) in sterile saline, HBSS (Hank's or RPMI) or
Formalin-fixed paraffin-embedded tissue (block or 10 unstained slides)
Fresh tissue (1 cm3) in sterile saline, HBSS (Hank's or RPMI) or
Formalin-fixed paraffin-embedded tissue (block or 10 unstained slides)
Minimum Volume
5 mL peripheral blood • 2 mL bone marrow • 1 cm3 fresh tissue
Instructions
Do not centrifuge
Transport Temperature
Blood, bone marrow, FFPE tissue: Refrigerated (cold packs)
Fresh tissue: Room temperature
Fresh tissue: Room temperature
Specimen Stability
Blood and bone marrow
Room temperature: 48 hours
Refrigerated: 15 days
Frozen: Unacceptable
Fresh tissue
Room temperature: 48 hours
Refrigerated: 48 hours
Frozen: Unacceptable
FFPE
Room temperature: Indefinitely
Refrigerated: Indefinitely
Frozen: Unacceptable
Room temperature: 48 hours
Refrigerated: 15 days
Frozen: Unacceptable
Fresh tissue
Room temperature: 48 hours
Refrigerated: 48 hours
Frozen: Unacceptable
FFPE
Room temperature: Indefinitely
Refrigerated: Indefinitely
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
Sets up 2 days a week.
Clinical Significance
Helps physicians diagnose and predict the course of disease progression for hematologic diseases.