Days Set Up
Monday - Friday
Analytic Time

3 - 10 days

MiChart Code
B Cell Clonality - IGH and IGK
Soft Order Code
IGHK

Test Updated:

Synonyms

B-Cell Clonality
IGH and IGK Gene Rearrangement
B Cell Gene Rearrangement
Gene Rearrangement, B-Cell
Gene Rearrangement, B Cell

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Test Overview

Test Methodology

Polymerase Chain Reaction (PCR) with capillary electrophoresis

Test Usage

B cell lymphoproliferative disorders are frequently associated with clonal rearrangements of the immunoglobulin heavy chain (IGH) and/or immunoglobulin kappa light chain (IGK) loci. Evaluation of the IGH locus may occasionally demonstrate clonal rearrangements not detected by IGK testing, and vice versa. This test employs multiplexed PCR primers to detect gene rearrangements involving the variable segments (frameworks regions 1, 2 and 3) and joining segments of the IGH locus as well as the variable, intragenic, joining and kappa deleting element regions of the IGK locus. In conjunction with clinical, morphologic and immunophenotypic data, the detection of these clonal rearrangements may be useful in the distinction of a lymphoproliferative disorder from a non-neoplastic process. In addition, the comparison of rearrangements detected within lymphocytic infiltrates from separate samples may be useful in determining their clonal relationship. The clinical implications of gene rearrangement results must always be interpreted in the context of the individual patient’s clinicopathologic presentation.

Reference Range

Interpretive report provided.
*Reference ranges may change over time. Please refer to the original patient report when evaluating results.

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Specimen Requirements

Collection Onsite

Collect blood or bone marrow in a lavender top tube. Refrigerate and send intact blood or bone marrow specimen within 48 hours of collection. Fresh tissue (preferably 0.5cm3, sent in RPMI) and fresh aspirates or body fluids are acceptable. Refrigerate and send, preferably within 24 hours. Frozen tissue specimens – preferably frozen with 1 hour of collection – may also be sent frozen on dry ice. Fresh cell suspensions in RPMI should be refrigerated and sent, preferably within 48 hours. Frozen cell suspensions – preferably frozen with 1 hour of collection – may also be sent frozen on dry ice. For formalin-fixed, paraffin-embedded tissue, a tissue block is preferred. Unstained, UNBAKED slides (5-8, 10-micron slides; 10-15 if few neoplastic cells are present) with associated H&E stained slide are also acceptable. Decalcified tissue or other fixatives will be accepted and the assay attempted, however these may result in failed testing due to degraded nucleic acid. Both blocks and slides should be stored at room temperature.

Collection Offsite

Collect blood or bone marrow in a lavender top tube. Refrigerate and send intact blood or bone marrow specimen within 48 hours of collection. Fresh tissue (preferably 0.5cm3, sent in RPMI) and fresh aspirates or body fluids are acceptable. Refrigerate and send, preferably within 24 hours. Frozen tissue specimens – preferably frozen with 1 hour of collection – may also be sent frozen on dry ice. Fresh cell suspensions in RPMI should be refrigerated and sent, preferably within 48 hours. Frozen cell suspensions – preferably frozen with 1 hour of collection – may also be sent frozen on dry ice. For formalin-fixed, paraffin-embedded tissue, a tissue block is preferred. Unstained, UNBAKED slides (5-8, 10-micron slides; 10-15 if few neoplastic cells are present) with associated H&E stained slide are also acceptable. Decalcified tissue or other fixatives will be accepted and the assay attempted, however these may result in failed testing due to degraded nucleic acid. Both blocks and slides should be stored at room temperature.

Normal Volume
5 mL EDTA (lavender) whole blood; 3 mL EDTA (lavender) bone marrow; Fresh/frozen tissue and fresh aspirates or body fluids; Fresh/frozen cells in RPMI; Formalin-fixed, paraffin-embedded tissue.
Extracted DNA is also acceptable if extracted in a CLIA certified laboratory.
Minimum Volume
 

Billing Information

CPT Code
81261, 81264
Pro Fee Code
 
LOINC
 

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Our High Standard

Quality that sets us apart

As the reference laboratory division of Michigan Medicine's Department of Pathology, MLabs shares the institution's commitment to applying established quality principles to clinical laboratory testing. Like other large organizations in complex, consequential fields, we rely on an established approach to monitor quality throughout the testing process.