Comparison of three different serum-free light-chain assays-implications on diagnostic and therapeutic monitoring of multiple myeloma.,Blood Cancer Journal

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Comparison of three different serum-free light-chain assays-implications on diagnostic and therapeutic monitoring of multiple myeloma.
Blood Cancer Journal ( IF 12.9 ) Pub Date : 2020-01-09 , DOI: 10.1038/s41408-019-0267-8
Aneta Schieferdecker ₁ , Sebastian Hörber _{2,

3,

4} , Monika Ums ₅ , Britta Besemer ₆ , Carsten Bokemeyer ₁ , Andreas Peter _{2,

3,

4} , Katja Weisel _{1,

6}

Affiliation

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.

中文翻译：

三种不同的无血清轻链检测方法的比较-对多发性骨髓瘤的诊断和治疗监测具有重要意义。

无血清轻链（FLC）的测量是多发性骨髓瘤（MM）的诊断和治疗的护理标准。修订后的国际骨髓瘤工作组（IMWG）实施了涉及的FLC /非参与性FLC（iFLC / niFLC）比作为需要治疗的MM的生物标记。最近，包括iFLC / niFLC比在内的高风险阴燃MM（SMM）的新定义发布了。这些建议仅基于单一测定方法（Freelite测定）。如今，还有两种附加的检测方法：N Latex FLC和基于ELISA的Sebia FLC。在这里，我们报告了一项单一中心研究，比较了FLC相关性的所有三种不同测定方法的结果及其对诊断和临床应用的潜在影响。总共检查了来自47个MM患者的187个样本，并进行了FLC测定。对比分析显示，Sebia FLC和N Latex FLC分析的FLC结果相似，与Freelite相比，κ/λ比的绝对值明显更低。λFLC的值表现出高可变性。在这些测定中，iFLC / niFLC的比率显示出显着差异。我们的数据表明，三种可用的测定法可能会导致结果明显不同，因此不应互换使用以监测患者。此外，建议修改SMM和MM的检测特定诊断（iFLC / niFLC）阈值。我们的数据表明，三种可用的测定法可能会导致结果明显不同，因此不应互换使用以监测患者。此外，建议修改SMM和MM的检测特定诊断（iFLC / niFLC）阈值。我们的数据表明，三种可用的测定法可能会导致结果明显不同，因此不应互换使用以监测患者。此外，建议修改SMM和MM的检测特定诊断（iFLC / niFLC）阈值。

更新日期：2020-01-09

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