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

Ton Langerak, PJTA Groenen, M Bruggemann, K Beldjord, C Bellan, L Bonello, E Boone, GI Carter, M Catherwood, F Davi, MH Delfau-Larue, T Diss, PAS Evans, P Gameiro, RG Sanz, D Gonzalez, D Grand, A Hakansson, M Hummel, H LiuL Lombardia, EA Macintyre, BJ Milner, S Montes-Moreno, E Schuuring, M Spaargaren, E Hodges, Jacques Dongen

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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 languageUndefined/Unknown
Pages (from-to)2159-2171
Number of pages13
Issue number10
Publication statusPublished - 2012

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  • EMC MM-02-72-01

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