Lab Test

Test Definition Number : 154
Test Definition Name : Immunoglobulin heavy rearrangement analysis
Lab Name : OHSU Knight Diagnostics Lab
Lab Test Number of THIS Version : 1171
Lab Test Name : B-Cell Gene Rearrangement
Status : Active
Expired : No
Updated : 2018-01-27 21:50 EST

General Attributes

Chromosome Band : 14q32.33
HUGO Gene Name : [IGH] immunoglobulin heavy locus
ICD-Oncology Code
(includes WHO classification diagnoses)

Infectious Disease Attributes

Agent Category :
Non-virus Genus and Species :
Virus Family, Genus, and Species :

Lab-specific Attributes

Method : Electrophoresis - Capillary
Polymerase Chain Reaction (PCR)
Specimen Source
(for clinical patient care these sources must be validated)
: Blood - Whole Blood
Bone Marrow Aspirate
Solid Tissue Paraffin-Embedded Formalin-Fixed
ICD-10 Code :
Use :
Genetics Category : Acquired (somatic)
Comments : Background: B-cell lymphomas account for greater than 90% of non-Hodgkin lymphomas and may pose a diagnostic challenge on the basis of histopathology alone. During normal B-cell maturation, the immunoglobulin heavy chain gene is rearranged such that each mature B-cell and plasma cell has a unique rearranged heavy chain gene profile. This process is vital to proliferation of B-cells in normal immune function, but can be exploited to aid in the distinction between reactive (benign) versus neoplastic processes of B-cell proliferation. A reactive, benign B-cell proliferation is characterized by polyclonal expansion of B-cells whereas a malignant process is often characterized by a clonal expansion of a predominant B-cell population. In conjunction with the histopathology study of lymph nodes, bone marrow and other tissue types, the detection of a clonal immunoglobulin heavy chain gene rearrangement by polymerase chain reaction (PCR) is intended as an aid in the diagnosis of malignant B-cell lymphoma. Clinical Utility: PCR-based detection of rearranged immunoglobulin heavy chain genes can be used as an aid to establish a diagnosis of a B-cell lymphoma, plasma cell malignancy, monitor treatment response, and/or measure minimal residual disease (MRD). Methodology: Genomic DNA is extracted from blood, lymph node, bone marrow, or other tissue types and the rearranged immunoglobulin heavy chain genes are amplified by PCR using a multiplex primer method based on the BIOMED-2 strategy. Precise fragment sizing of the amplicons is accomplished using capillary gel electrophoresis. The presence or absence of a monoclonal population is determined based on the overall analysis of the gel electrophoretic pattern. Clinical Sensitivity: > 95% for the detection of clonality in most tissue types. Clinical Specificity: As cross-lineage immunoglobulin heavy chain gene rearrangements have been reported in certain T-cell malignancies, interpretation of this test requires clinical, morphologic, and immunophenotypic correlation.
Specimen Transport Requirements : 5-10 mL of blood or bone marrow — yellow (ACD) or purple (EDTA) tube. Store and ship refrigerated. If sending DNA, please send 200ng at a minimum of 10ng/µL. Formalin-fixed paraffin-embedded (FFPE) tissue blocks or 10 slides (5 microns). Store and ship at room temperature. Pathology report MUST accompany sample for interpretation of results. Ship via overnight express. Contact Client Services at (855) 535-1522 for shipping kits and instructions.
Samples Available for Proficiency Test Sample Exchange : Yes


Copyright © 2015, Association for Molecular Pathology