B-cell Clonality Panel (IGH, IGK), PCR
Test Summary
This assay, which interrogates the immunoglobulin kappa light chain gene (IGK) and the immunoglobulin heavy chain (IGH), by a PCR method based on the BIOMED-2 consensus, is useful for establishing clonality of B-cell lymphoid neoplasms. It can be used also for identification of minimal residual disease or early recurrence in patients with a previous diagnosis of a B-cell neoplasm. Testing for both IGH and IGK gene rearrangements is reported to detect up to 99% of B-cell malignancies, compared to 80-90% for IGH and 85-90% for IGK alone.
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 (e.g. 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 (e.g. 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 and bone marrow aspirate
- Room temperature: 7 days
- Refrigerated: 7 days
- Frozen: Unacceptable
- FFPE tissue/slides
- Room temperature: 5 years
- Refrigerated: 5 years
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
BCCP
EPIC (Premier) Code
LAB5394
Includes
Test includes pathologist interpretation
CPT Code
- 81261
- 81264
- 84999 (HCPCS: G0452)
Billing Code
- 671322
- 671323
- 671324
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 (e.g. 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 (e.g. 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 and bone marrow aspirate
- Room temperature: 7 days
- Refrigerated: 7 days
- Frozen: Unacceptable
- FFPE tissue/slides
- Room temperature: 5 years
- Refrigerated: 5 years
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
- 84999 (HCPCS: G0452)
Billing Code
- 671322
- 671323
- 671324
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