Inter-assay variability in automated serum free light chain assays and their use in the clinical laboratory

Crit Rev Clin Lab Sci. 2020 Mar;57(2):73-85. doi: 10.1080/10408363.2019.1670133. Epub 2019 Oct 15.

Abstract

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.

Keywords: Free light chains; amyloidosis; dimers; monoclonal gammopathy of undetermined significance; monomers; multiple myeloma; plasma cell dyscrasias; smoldering multiple myeloma.

Publication types

  • Review

MeSH terms

  • Clinical Laboratory Services
  • Humans
  • Immunoglobulin Light Chains / analysis*
  • Immunoglobulin Light Chains / blood
  • Immunoglobulin Light Chains / immunology
  • Immunoglobulin kappa-Chains / analysis*
  • Immunoglobulin kappa-Chains / blood
  • Immunoglobulin lambda-Chains / analysis*
  • Immunoglobulin lambda-Chains / blood
  • Laboratories
  • Paraproteinemias / blood
  • Paraproteinemias / diagnosis
  • Reproducibility of Results

Substances

  • Immunoglobulin Light Chains
  • Immunoglobulin kappa-Chains
  • Immunoglobulin lambda-Chains