Abstract
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 language | English |
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Pages (from-to) | 2159-2171 |
Number of pages | 13 |
Journal | Leukemia |
Volume | 26 |
Issue number | 10 |
DOIs | |
Publication status | Published - Oct 2012 |
Keywords
- DNA
- Gene Rearrangement
- Guidelines as Topic
- Humans
- Immunoglobulins
- Lymphoproliferative Disorders
- Multiplex Polymerase Chain Reaction
- Receptors, Antigen, T-Cell