Performance Evaluation of Serum Free Light Chain Analysis: Nephelometry vs Turbidimetry, Monoclonal vs Polyclonal Reagents

Am J Clin Pathol. 2017 Jun 1;147(6):611-622. doi: 10.1093/ajcp/aqx037.

Abstract

Objectives: Free light chain (FLC) measurement gained a lot of interest for diagnostic workup of monoclonal gammopathy.

Methods: We evaluated the performance of turbidimetric polyclonal Freelite (The Binding Site, Birmingham, UK) assays on Cobas 6000 (Roche Diagnostics, Rotkreuz, Switzerland) and nephelometric monoclonal N Latex (Siemens Healthcare Diagnostics, Marburg, Germany) assays on BN ProSpec (Dade Behring, Deerfield, IL) vs established nephelometric Freelite assays on BN ProSpec.

Results: Analytical performance was acceptable. Method comparison (n = 118) showed significant proportional FLC differences for N Latex assays. However, good correlation and clinical concordance were shown. Recovery study in the low concentration range demonstrated consistent over- and underrecovery for Freelite reagents, hampering future research on prognostic value of suppressed noninvolved FLC. Antigen excess detection was successful for κ FLC in three-fourths of cases with Freelite reagents and in all cases with N Latex reagents. However, the latter resulted in underestimated κ FLC concentrations.

Conclusions: FLC analysis requires continuous awareness of analytical limitations. Monitoring of disease response requires FLC analysis on the same platform using the same reagents.

Keywords: Free light chains; Monoclonal; Monoclonal gammopathy; Myeloma; Nephelometry; Polyclonal; Turbidimetry.

Publication types

  • Evaluation Study

MeSH terms

  • Antibodies, Monoclonal / immunology
  • Humans
  • Immunoglobulin Light Chains / blood*
  • Immunoglobulin Light Chains / immunology
  • Immunoglobulin kappa-Chains / blood*
  • Immunoglobulin kappa-Chains / immunology
  • Immunoglobulin lambda-Chains / blood*
  • Immunoglobulin lambda-Chains / immunology
  • Nephelometry and Turbidimetry / methods*
  • Paraproteinemias / diagnosis*
  • Paraproteinemias / immunology
  • Prognosis
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity

Substances

  • Antibodies, Monoclonal
  • Immunoglobulin Light Chains
  • Immunoglobulin kappa-Chains
  • Immunoglobulin lambda-Chains
  • Reagent Kits, Diagnostic