BIOMED-2 PCR protocol

Guideline of the "EuroClonality (BIOMED-2) Consortium" in which important pre- and post-analytical aspects of clonality tests are summarized. The consortium provides guidelines for the interpretation of clonality test results and presents a uniform method for reporting Ig/TCR test results.

PCR-based immunoglobulin (Ig)/T-cell receptor (TCR) clonality tests for suspected lymphoproliferations have been largely standardized and have therefore become technically feasible in routine diagnostics. Standardization of the pre- and postanalytical phases is crucial to avoid misinterpretation and false conclusions from clonality data. Since clonality testing is not a quantitative assay but rather the detection of molecular patterns, guidelines for reliable interpretation and reporting are essential.

Based on an immunobiological concept, two levels for reporting Ig/TCR profiles are distinguished: the technical description of individual (multiplex) PCR reactions and the general molecular inference for B and T cells. Overall, the EuroClonality (BIOMED-2) guidelines and consensus reporting system should help to improve the general level of performance of clonality assessment and interpretation, which will have a direct impact on the routine clinical management (standardised best practice) of patients with suspected lymphoproliferations.