Serum κ and λ free light chain levels are markers of plasma cell proliferation, and their measurements have been included in recent guidelines by the International Myeloma Working Group for the management of patients with plasma cellular dyscrasias. Five in vitro diagnostic methods for the immunochemical quantification of serum free light chains (FLC) are available, three based on polyclonal antibodies (Freelite®, The Binding Site; FLC ELISA κ and λ, Sebia; human κ and λ FLC, Diazyme Laboratories) and two on monoclonal antibodies (N Latex FLC, Siemens Healthineers; Seralite®, Sebia). Several studies have shown that these methods cannot be used interchangeably for the follow-up of patients because measured κ and λ FLC concentrations may differ significantly, especially at high levels. Because no international reference material for the measurement of FLC is available, it is not possible to establish which method is the most accurate. For this reason, knowledge about the analytical and diagnostic performances of the assays used is important. The aim of this review is to describe the main analytical features of the κ and λ FLC assays and how they may influence the clinical use of these parameters.

中文翻译：

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自动无血清轻链测定法中的测定间变异性及其在临床实验室中的使用。

血清κ和λ游离轻链水平是浆细胞增殖的标志物，国际骨髓瘤工作组已将其测量值纳入近期指南中，以治疗浆细胞异常型患者。有五种用于免疫化学定量血清游离轻链（FLC）的体外诊断方法，其中三种基于多克隆抗体（Freelite®，结合位点； FLC ELISAκ和λ，Sebia；人κ和λFLC，Diazyme Laboratories）另两种是单克隆抗体（N Latex FLC，Siemens Healthineers；Seralite®，Sebia）。多项研究表明，这些方法不能随心所欲地用于患者的随访，因为测量的κ和λFLC浓度可能存在显着差异，尤其是在高水平下。由于没有用于测量FLC的国际参考材料，因此无法确定哪种方法最准确。因此，有关所用测定法的分析和诊断性能的知识很重要。这篇综述的目的是描述κ和λFLC分析的主要分析特征，以及它们如何影响这些参数的临床使用。