Lymphocyte Clonality Panel, PCR
Order Code:
LYMPCP
Test Summary
This assay interrogates simultaneously the immunoglobulin kappa (IGK), the immunoglobulin heavy chain (IGH), the T-cell receptor beta (TCRB) and the T-cell receptor gamma (TCRG) genes by PCR methods based on the BIOMED-2 consensus. This combination assay will be most useful in diagnosing mixed B-cell and T-cell atypical infiltrates and for lineage identification in poorly differentiated or immature lymphoid malignancies.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
5 mL whole blood or 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube • 8 unstained positively charged slides
Minimum Volume
3 mL whole blood • 1 mL bone marrow aspirate • 4 slides • 1 block
Instructions
Do not reject specimens, send to laboratory for screening.
8 unstained sections on glass slides labeled with surgical case number (pathology report required, indicate if fixative is not formalin) Please include pathology report for frozen tissue and FFPE cases (partial/preliminary reports acceptable).
Needle washings (acceptable): in alcohol based fixative (eg. CytoLyt) are acceptable.
8 unstained sections on glass slides labeled with surgical case number (pathology report required, indicate if fixative is not formalin) Please include pathology report for frozen tissue and FFPE cases (partial/preliminary reports acceptable).
Needle washings (acceptable): in alcohol based fixative (eg. CytoLyt) are acceptable.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Fresh tissue: Frozen
All other specimens: Room temperature
All other specimens: Room temperature
Specimen Stability
- Whole blood/Bone marrow aspirate
- Room temperature: 7 days
- Refrigerated: 7 days
- Frozen: Unacceptable
- FFPE/Slides
- Room temperature: 5 years
- Refrigerated: 5 years
- Froze
Limitations
N/A
Other Acceptable Specimens
Whole blood or bone marrow aspirate collected in a sodium heparin (green-top) tube • Formalin-fixed, paraffin-embedded tissue • Fresh tissue • Tissues in formalin fixative or RPMI
Unacceptable Specimens
N/A
Order Code
LYMPCP
EPIC (Premier) Code
LAB5398
Includes
B-cell Gene Rearrangement (IGH, IGK)
T-cell Gene Rearrangement (TCRG, TCRB)
Pathologist Interpretation
T-cell Gene Rearrangement (TCRG, TCRB)
Pathologist Interpretation
CPT Code
- 81261
- 81264
- 81340
- 81342
- 84999 (HCPCS: G0452)
Billing Code
- 671202
- 671203
- 671204
- 671205
- 671206
CPT Statement
Methodology
Polymerase Chain Reaction (PCR) • Fragment Analysis
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
33608 Ortega Highway
San Juan Capistrano CA, 92675
33608 Ortega Highway
San Juan Capistrano CA, 92675
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 aspirate collected in an EDTA (lavender-top) tube • 8 unstained positively charged slides
Minimum Volume
3 mL whole blood • 1 mL bone marrow aspirate • 4 slides • 1 block
Instructions
Do not reject specimens, send to laboratory for screening.
8 unstained sections on glass slides labeled with surgical case number (pathology report required, indicate if fixative is not formalin) Please include pathology report for frozen tissue and FFPE cases (partial/preliminary reports acceptable).
Needle washings (acceptable): in alcohol based fixative (eg. CytoLyt) are acceptable.
8 unstained sections on glass slides labeled with surgical case number (pathology report required, indicate if fixative is not formalin) Please include pathology report for frozen tissue and FFPE cases (partial/preliminary reports acceptable).
Needle washings (acceptable): in alcohol based fixative (eg. CytoLyt) are acceptable.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Fresh tissue: Frozen
All other specimens: Room temperature
All other specimens: Room temperature
Specimen Stability
- Whole blood/Bone marrow aspirate
- Room temperature: 7 days
- Refrigerated: 7 days
- Frozen: Unacceptable
- FFPE/Slides
- Room temperature: 5 years
- Refrigerated: 5 years
- Froze
Limitations
N/A
Other Acceptable Specimens
Whole blood or bone marrow aspirate collected in a sodium heparin (green-top) tube • Formalin-fixed, paraffin-embedded tissue • Fresh tissue • Tissues in formalin fixative or RPMI
Unacceptable Specimens
N/A
Billing
CPT Code
- 81261
- 81264
- 81340
- 81342
- 84999 (HCPCS: G0452)
Billing Code
- 671202
- 671203
- 671204
- 671205
- 671206
CPT Statement
Result Information
Methodology
Polymerase Chain Reaction (PCR) • Fragment Analysis
Testing Laboratory
N/A
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Daily; Report available: 5 days