title: Clonality analysis of lymphoid proliferations using the BIOMED-2 clonality assays: a single institution experience.
abstract: BACKGROUND
  Clonality determination in patients with lymphoproliferative disorders can improve the final diagnosis. The aim of our study was to evaluate the applicative value of standardized BIOMED-2 gene clonality assay protocols for the analysis of clonality of lymphocytes in a group of different lymphoid proliferations.
  
  
  METHODS
  With this purpose, 121 specimens from 91 patients with suspected lymphoproliferations submitted for routine diagnostics from January to December 2011 were retrospectively analyzed. According to the final diagnosis, our series comprised 32 cases of B-cell lymphomas, 38 cases of non-Hodgkin's T-cell lymphomas and 51 cases of reactive lymphoid proliferations. Clonality testing was performed using the BIOMED-2 clonality assays.
  
  
  RESULTS
  The determined sensitivity of the TCR assay was 91.9%, while the sensitivity of the IGH assay was 74.2%. The determined specificity of the IGH assay was 73.3% in the group of lymphomas and 87.2% in the group of reactive lesions. The determined specificity of the TCR assay was 62.5% in the group of lymphomas and 54.3% in the group of reactive lesions.
  
  
  CONCLUSIONS
  In the present study, we confirmed the utility of standardized BIOMED-2 clonality assays for the detection of clonality in a routine diagnostical setting of non-Hodgkin's lymphomas. Reactions for the detection of the complete IGH rearrangements and reactions for the detection of the TCR rearrangements are a good choice for clonality testing of a wide range of lymphoid proliferations and specimen types while the reactions for the detection of incomplete IGH rearrangements have not shown any additional diagnostic value.
authors.affiliation: Department of Molecular Diagnostics, Institute of Oncology Ljubljana, Ljubljana, Slovenia.
authors.forename: Ira
authors.initials: I
authors.lastname: Kokovic
authors.affiliation: Department of Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia.
authors.forename: Barbara Jezersek
authors.initials: BJ
authors.lastname: Novakovic
authors.affiliation: Department of Molecular Diagnostics, Institute of Oncology Ljubljana, Ljubljana, Slovenia.
authors.forename: Petra
authors.initials: P
authors.lastname: Cerkovnik
authors.affiliation: Department of Molecular Diagnostics, Institute of Oncology Ljubljana, Ljubljana, Slovenia.
authors.forename: Srdjan
authors.initials: S
authors.lastname: Novakovic
keywords: BIOMED-2; IGH rearrangement; TCR rearrangement; clonality analysis; lymphomas