Evaluation of the Impact of Renal Failure on Correlation and Concordance Between 2 Free Light Chain Assays

Abstract

Background: Free light chain (FLC) assays are essential for diagnosis and follow-up of plasma cell dyscrasia. Two assays are available: Freelite (Binding Site) and N Latex FLC (Siemens). The aim of our study was to evaluate the impact of renal failure on concordance and correlation between the 2 FLC assays.

Methods: FLC measurements using both assays were performed on 1215 fresh serum samples from patients with or without monoclonal gammopathy and renal failure. Concordance and correlation were evaluated using Passing-Bablock regression, Pearson correlation coefficient, and the Cohen kappa coefficient, taking into account the renal failure stage (evaluated with Chronic Kidney Disease-Epidemiology Collaboration formulae) and evaluation of treatment response in patients' follow-up.

Results: A good correlation was demonstrated between both assays, irrespective of the renal failure stage (Pearson correlation coefficient > 0.90). For FLC ratio interpretation, there remained 7.6% to 20.8% discordances between the 2 methods throughout the whole range of renal impairment. To evaluate FLC evolution in patient follow-up, 41 patients were selected with at least 6 consecutive serum samples being collected during the study period: we observed a concordant evolution of FLC concentrations between both assays. However, few discrepancies were observed with 4 patients.

Conclusions: Despite adjusted reference ranges for Freelite FLC ratio, there are approximately 12.5% discrepancies in interpretation of FLC ratio between the 2 available assays. They are not linked to renal failure stage and neither of the assays performed better than the other: results must be interpreted taking into account clinical data and the same assay must be used for patient follow-up.

Keywords: Chronic kidney disease; FLC interpretation; Free light chains; Monoclonal gammopathy; Multiple myeloma.