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- IGK Gene Clonality Assay
This assay can be used to detect clonal immunoglobulin receptor kappa-chain gene rearrangements in blood, bone marrow, and tissue specimens with combined B-cell clonality detection rate of 94% to 99%. The presence of a monoclonal gene rearrangement usually, but not always, reflects the presence of a T-lymphocytic neoplasm, while polyclonal gene rearrangement patterns are found in benign reactive conditions. Thus, the results of these studies can assist in the diagnosis of lymphoproliferative disorders.
This PCR assay is able to detect a clonal DNA population at the sensitivity of 5% in a background of polyclonal DNA.
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.
Polymerase chain reaction (PCR)
Whole blood, bone marrow, formalin-fixed, paraffin-embedded (FFPE) tissue block or slides, fresh or frozen tissue
3 to 5 mL whole blood, 1 mL bone marrow, five unstained slides at 10 uM or formalin-fixed, paraffin-embedded tissue block, tissue in RPMI or frozen
0.5 mL whole blood or 0.5 mL bone marrow, two unstained slides at 10uM
Fresh tissue should be placed in RPMI medium or shipped frozen on dry ice. Small samples (eg, punch biopsies, fine-needle aspirates) will also be accepted. To avoid delays in turnaround time when requesting multiple test on frozen samples, please submit separate specimens for each test requested.
Maintain whole blood, bone marrow or tissue in RPMI at 2°C to 8°C; FFPE specimens at room temperature; frozen tissue at -80°C.
Causes for Rejection
Frozen whole blood/bone marrow; quantity not sufficient for analysis; tumor block containing no tumor tissue; broken or stained slides
Please direct any questions regarding this test to customer service at 800-345-4363.
|Order Code||Order Code Name||Order Loinc||Result Code||Result Code Name||UofM||Result LOINC|
|480812||IgK Gene Rearrangement, PCR||480813||IgK PCR Interpretation||21748-9|
|480812||IgK Gene Rearrangement, PCR||480828||K Clonal Size||N/A|
|480812||IgK Gene Rearrangement, PCR||480777||Block Number:||N/A|
|480812||IgK Gene Rearrangement, PCR||489028||Director Review||72486-4|
|480812||IgK Gene Rearrangement, PCR||480831||Methodology:||49549-9|
|480812||IgK Gene Rearrangement, PCR||480821||References:||N/A|