Caroline Moreau1, Brice Autier2, Thibault Cavey3, Emmanuel Rouger2, James Norwood4, Claude Bendavid3, Martine Escoffre4, Martine Sébillot5, Olivier Decaux5. 1. Laboratory of Biochemistry and Toxicology, University Hospital Center, Rennes, France; INSERM U-991, University of Rennes 1, Rennes, France. Electronic address: caroline.moreau@chu-rennes.fr. 2. Laboratory of Biochemistry and Toxicology, University Hospital Center, Rennes, France. 3. Laboratory of Biochemistry and Toxicology, University Hospital Center, Rennes, France; INSERM U-991, University of Rennes 1, Rennes, France. 4. Department of Clinical Hematology, University Hospital Center, Rennes, France. 5. Department of Internal Medicine, University Hospital Center, Rennes, France.
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. Copyright Â
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. Copyright Â