EuroClonality/BIOMED-2 guidelines for interpretation and reporting of Ig/TCR clonality testing in suspected lymphoproliferations.
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.
Department of Immunology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands. a.langerak@erasmusmc.nl
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Langerak
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Groenen
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Brüggemann
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Beldjord
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Bellan
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Bonello
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Boone
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Carter
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Catherwood
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Davi
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Delfau-Larue
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Evans
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Gameiro
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Garcia Sanz
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Grand
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Håkansson
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Hummel
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Liu
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Lombardia
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Macintyre
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Milner
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Montes-Moreno
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Schuuring
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Hodges
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van Dongen
D004247:DNA / Q000032:analysis; D015321:Gene Rearrangement; D017408:Guidelines as Topic; D006801:Humans; D007136:Immunoglobulins / Q000235:genetics*; D008232:Lymphoproliferative Disorders / Q000175:diagnosis* / Q000235:genetics; D060885:Multiplex Polymerase Chain Reaction; D011948:Receptors, Antigen, T-Cell / Q000235:genetics*
D007136:Immunoglobulins; D011948:Receptors, Antigen, T-Cell; D004247:DNA