Product Availability Key

  • Outside North America flagOutside North America
  • Outside North America flag

CAT #: 91010101

IdentiClone® Dx IGH Assay

Intended Use

The IdentiClone Dx IGH Assay (“Assay”) is an in vitro diagnostic device intended for capillary electrophoresis based-detection of clonality in immunoglobulin heavy chain (IGH) gene rearrangements in peripheral blood specimens as an adjunctive method for the diagnosis of patients suspected to have a B-cell lymphoproliferative disease.

Positive results (i.e., the detection of clonality) should not be the sole criterion for determining the presence of disease.  Negative results do not preclude lymphoproliferative disease.  The use of additional laboratory testing (e.g., white blood cell [WBC] counts, morphology, immunohistochemistry, detection of driver mutations, flow cytometry, etc.) and clinical presentation must be taken into consideration in the final diagnosis of lymphoproliferative disease.

This qualitative, non-automated Assay is for use with ABI 3500xL Dx and ABI 3500xL Genetic Analyzers.

Product Details

  • Summary and Explanation of the Test

    B-cell lymphoproliferative disorders, including various lymphomas and leukemias, are diagnosed in over 900,000 patients worldwide each year.1,2,3 A defining feature of these malignancies is the presence of clonal immunoglobulin heavy chain (IGH) gene rearrangements, resulting from dysregulation of normal B-cell development.

    During ontogeny, B lymphocytes undergo V(D)J recombination, where the variable (VH), diversity (DH), and joining (JH) gene segments rearrange to create up to 10¹² unique DNA sequences.4,5  This diversity underpins antigen recognition; however, in malignancy, clonal expansion of a single B cell with a unique IGH rearrangement generates a dominant population that can be distinguished from polyclonal repertoires.  Detection of such clonal IGH rearrangements is a well-established hallmark of B-cell malignancy and plays a critical role in diagnosis, classification, and monitoring.6,7,8,9

    PCR-based approaches remain a gold-standard front-line method for clonality assessment, providing rapid and cost-efficient information to confirm or exclude a clonal process prior to more comprehensive molecular analyses.10,11,12,13

  • Specimen Requirements

    This assay requires at least 0.5 mL of peripheral blood anti-coagulated with EDTA.

  • Overview

    The IdentiClone Dx IGH Assay is an IVDR Class C–certified, PCR-based diagnostic assay designed to identify clonal immunoglobulin heavy chain (IGH) gene rearrangements.  The assay includes three PCR master mixes, fluorescently labeled consensus primers targeting the IGH framework regions (FR1, FR2, and FR3) within the VH and JH segments, along with positive, negative, and no-template controls, Taq DNA polymerase, and the IdentiClone Dx IGH Software Package.

    Genomic DNA from peripheral blood specimens is amplified using the master mixes, generating fluorescently labeled amplicons corresponding to IGH rearrangements.  The PCR products are then separated by capillary electrophoresis to produce size-based amplicon profiles.  These data are uploaded into the IdentiClone Dx IGH Software, which evaluates assay validity and determines clonality status.  Results from all valid master mixes are integrated to assign a final interpretation for each specimen: Clonal, Non-Clonal, Indeterminate, or Invalid.

References

1.  Bray F, et al.  CA: A Cancer Journal for Clinicians, 2024; 74:229–263.
2.  
Siegel RL, et al.  CA: A Cancer Journal for Clinicians, 2020; 70:7-30.
3.  
Cowan AJ, et al.  J Am Med, 2018 Sep; 4(9):1221-1227.
4.  
Miller JE, et al.  Mol Diag, 1999; 4(2):101-117.
5.  
van Dongen JJM, et al.  Leukemia, 2004 Jan; 17(12):2257–2317.
6.  
Van Krieken JHJM ,et al.  Leukemia, 2007 Feb; 21(2):201-206.
7.  
Evans PAS, et al.  Leukemia, 2007 Mar; 21(2):207-214.
8.  
Hongxiang L, et al. Brit J Haematol, 2007 Jul; 138(1):31-43.
9.  
Langerak AW, et al.  Leukemia, 2012 Aug; 26(10):2159-2171.
10.  Hongxin F and Robetorye RS. Mthd Mol Biol, 2013; 999:151-167.
11.  
Kokovic I, et al. Radiology and Oncology, 2014 Jun; 48(2):155-162.
12.  
Roepman P, et al.  J Clin Path, Published Online First: [12 May 2016] doi:10.1136/jclinpath-2016-203757
13.  
Zhang J-J, et al.  Bioengineered, 2022; 13:3, 5868-5879.

Disclaimer

This is a CE-2797 IVD product intended for in vitro diagnostic use.  Not available in North America.

Legal Notice

Now Available

Our New Document Search Feature
SEARCH ⟶

Need Help Placing an Online Order?

Contact our Customer Service Team
CONTACT CUSTOMER SERVICE ⟶

Now Available

Our New Document Search Feature
SEARCH ⟶

Need Help Placing an Online Order?

Contact our Customer Service Team
CONTACT CUSTOMER SERVICE ⟶