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B-cell Receptor IGH Gene Rearrangement, PCR
Test Code90362
CPT Codes
81261, 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 or 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube or
8 unstained charged (+) slides
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 heavy chain gene (IGH) by a PCR method based on the BIOMED-2 consensus, is useful for establishing clonality of B-cell neoplasms and in the identification of minimal residual disease or early recurrence in patients with a previous diagnosis of a B-cell neoplasm. It can be used in association with the immunoglobulin kappa light chain (IGK test code 90363, or IDH/IGK combo test code 91635), since false-negative results can occur in up to 10-20% of B-cell malignancies when testing for IGH only. The highest rates of non-detectable IGH clonal rearrangements are in IGV- mutated B-cell neoplasms such as follicular lymphoma and plasma cell neoplasms and in B-lymphoblastic leukemia/lymphoma due to absent or incomplete B-cell receptor rearrangements.
Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153