EuroClonality/BIOMED-2 guidelines for interpretation and reporting of Ig/TCR clonality testing in suspected lymphoproliferations.

A.W. Langerak, P.J. Groenen, M. Brüggemann, K. Beldjord, C. Bellan, L. Bonello, E. Boone, G.I. Carter, M. Catherwood, F. Davi, M.H. Delfau-Larue, T. Diss, P.A. Evans, P. Gameiro, R. Garcia Sanz, D. Gonzalez, D. Grand, A. Håkansson, M. Hummel, H. LiuL. Lombardia, E.A. Macintyre, B.J. Milner, S. Montes-Moreno, E. Schuuring, M. Spaargaren, E. Hodges, J.J. van Dongen

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264 Citations (Scopus)


PCR-based immunoglobulin (Ig)/T-cell receptor (TCR) clonality testing in suspected lymphoproliferations has largely been standardized and has consequently become technically feasible in a routine diagnostic setting. Standardization of the pre-analytical and post-analytical phases is now essential to prevent misinterpretation and incorrect conclusions derived from clonality data. As clonality testing is not a quantitative assay, but rather concerns recognition of molecular patterns, guidelines for reliable interpretation and reporting are mandatory. Here, the EuroClonality (BIOMED-2) consortium summarizes important pre- and post-analytical aspects of clonality testing, provides guidelines for interpretation of clonality testing results, and presents a uniform way to report the results of the Ig/TCR assays. Starting from an immunobiological concept, two levels to report Ig/TCR profiles are discerned: the technical description of individual (multiplex) PCR reactions and the overall molecular conclusion for B and T cells. Collectively, the EuroClonality (BIOMED-2) guidelines and consensus reporting system should help to improve the general performance level of clonality assessment and interpretation, which will directly impact on routine clinical management (standardized best-practice) in patients with suspected lymphoproliferations.
Original languageEnglish
Pages (from-to)2159-2171
Number of pages13
Issue number10
Publication statusPublished - Oct 2012


  • DNA
  • Gene Rearrangement
  • Guidelines as Topic
  • Humans
  • Immunoglobulins
  • Lymphoproliferative Disorders
  • Multiplex Polymerase Chain Reaction
  • Receptors, Antigen, T-Cell


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