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B-cell Clonality Panel (IGH, IGK), PCR
Test Code91635
CPT Codes
81261, 81264, 84999 (HCPCS: G0452)<br><strong>CPT coding may differ dependent on payer rules which may impact prior authorization testing.</strong><br><strong>Please direct any questions regarding CPT coding to the payer being billed.</strong>
Includes
Test includes pathologist interpretation
Preferred Specimen
5 mL whole blood collected in an EDTA (lavender-top) tube or
3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube or
8 unstained charged (+) slides
3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube or
8 unstained charged (+) slides
Minimum Volume
3 mL whole blood • 1 mL bone marrow aspirate • 4 unstained charged (+) slides • 1 block
Other Acceptable Specimens
Whole blood or bone marrow aspirate collected in: Sodium heparin (green-top) tube • Formalin-fixed paraffin-embedded tissue, fresh tissue, or tissues in formalin fixative or RPMI
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.
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
Frozen: Unacceptable
Fresh tissue
Room temperature: See Collection Instructions
Refrigerated: See Collection Instructions
Frozen -20° C: See Collection Instructions
Frozen -70° C: 1 year
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable
FFPE tissue/slides
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Fresh tissue
Room temperature: See Collection Instructions
Refrigerated: See Collection Instructions
Frozen -20° C: See Collection Instructions
Frozen -70° C: 1 year
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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Daily; Report available: 5 days
Reference Range
See Laboratory Report
Clinical Significance
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.
Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153