三种不同血清游离轻链检测方法的比较——对多发性骨髓瘤诊断和治疗监测的影响
Comparison of three different serum-free light-chain assays—implications on diagnostic and therapeutic monitoring of multiple myeloma
原文发布日期:2020-01-09
DOI: 10.1038/s41408-019-0267-8
类型: Article
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The measurement of serum-free light chains (FLC) is standard of care in the diagnosis and management of multiple myeloma (MM). The revised international myeloma working group (IMWG) implemented the involved FLC/noninvolved FLC (iFLC/niFLC) ratio as a biomarker for MM requiring treatment. Recently, a new definition of high-risk smoldering MM (SMM) including iFLC/niFLC ratio was published. These recommendations were solely based on a single assay method (Freelite assay). Today, two additional assays, N Latex FLC and ELISA-based Sebia FLC, are available. Here, we report on a single-center-study comparing results of all three different assays for FLC correlation and its potential implications for diagnostic and clinical use. In total, 187 samples from 47 MM patients were examined, and determination of FLC was performed. Comparison analyses showed similar FLC results for Sebia FLC and N Latex FLC assay with markedly lower absolute values for κ/λ ratio compared with Freelite. Values of λ FLC exhibited high variability. The ratio of iFLC/niFLC showed significant discrepancies among these assays. Our data demonstrate that the three available assays may result in markedly discrepant results, and should not be used interchangeably to monitor patients. Furthermore, modifications of the assay-specific diagnostic (iFLC/niFLC) thresholds for SMM and MM are recommended.
血清游离轻链(FLC)的检测是多发性骨髓瘤(MM)诊断和管理中的标准诊疗手段。修订后的国际骨髓瘤工作组(IMWG)将受累FLC/未受累FLC(iFLC/niFLC)比率作为需要治疗的多发性骨髓瘤的生物标志物。近期,新发布的高危冒烟型骨髓瘤(SMM)定义纳入了iFLC/niFLC比率。这些建议仅基于单一检测方法(Freelite检测法)。目前,另有两种检测方法可供使用:N Latex FLC和基于ELISA的Sebia FLC。本文报告了一项单中心研究,比较了所有三种不同检测方法的FLC相关性结果及其对诊断和临床应用的潜在影响。研究共检测了47例多发性骨髓瘤患者的187份样本,并进行了FLC测定。对比分析显示,Sebia FLC和N Latex FLC检测法的FLC结果相似,但κ/λ比率的绝对值明显低于Freelite法。λ FLC的数值表现出高度变异性。iFLC/niFLC比率在这些检测方法间存在显著差异。我们的数据表明,现有三种检测方法可能产生明显不一致的结果,不应互换用于患者监测。此外,建议针对冒烟型骨髓瘤和多发性骨髓瘤的特定检测方法(iFLC/niFLC)诊断阈值进行调整。
Comparison of three different serum-free light-chain assays—implications on diagnostic and therapeutic monitoring of multiple myeloma
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