EuroClonality/BIOMED-2 guidelines for interpretation and reporting of Ig/TCR clonality testing in suspected lymphoproliferations.
EuroClonality/BIOMED-2 guidelines for interpretation and reporting of Ig/TCR clonality testing in suspected lymphoproliferations.
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基于PCR的免疫球蛋白（IG）/T细胞受体（TCR）克隆性检测在疑似淋巴细胞增生中已基本标准化，因此在常规诊断环境中在技术上可行。现在，分析前和分析后阶段的标准化对于防止从克隆性数据中得出的误解和不正确的结论至关重要。由于克隆性检测不是定量分析，而是涉及分子模式的识别，因此必须制定可靠解释和报告指南。在此，欧洲克隆性（BIOMED-2）联盟总结了克隆性检测的重要分析前和分析后方面，提供了解释克隆性检测结果的指南，并提出了报告IG/TCR检测结果的统一方法。从免疫生物学概念出发，区分两个水平来报告IG/TCR谱：单个（多重）PCR反应的技术描述和B和T细胞的总体分子结论。总的来说，欧洲克隆性（BIOMED-2）指南和共识报告系统应有助于提高克隆性评估和解释的一般性能水平，这将直接影响疑似淋巴细胞增生患者的常规临床管理（标准化最佳实践）。
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.