Serum free light chain reference intervals in an Optilite and their influence on clinical guidelines |
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| Institution: | 1. Department of Laboratory Medicine, Zhongshan Hospital, Fudan University, 180 Feng Lin Road, Shanghai 200032, PR China;2. Department of Medical Oncology, Zhongshan Hospital, Fudan University, 180 Feng Lin Road, Shanghai 200032, PR China;3. Department of Laboratory Medicine, Xiamen Branch, Zhongshan Hospital, Fudan University, 668 Jin Hu Road, Xiamen 361015, PR China;4. Department of Laboratory Medicine, Wusong Branch, Zhongshan Hospital, Fudan University, 101 Tong Tai North Road, Shanghai 200940, PR China;1. Department of Laboratory Medicine and Pathology, Mayo Clinic Arizona, 13400 E Shea Boulevard, Scottsdale, AZ 85259, USA;1. Clinical Laboratory, Biochemistry Department, Parc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí I3PT, Sabadell, Spain;2. Paediatrics Department, Parc Taulí Hospital Universitari, Sabadell, Spain;1. Department of Biophysics and Pharmacology, Institute of Biosciences of Botucatu, Universidade Estadual Paulista, Distrito Rubiao Junior, Botucatu, São Paulo 18680-000, Brazil;2. Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm 17177, Sweden;3. Department of Gynecology and Obstetrics, Faculty of Medicine of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, Sao Paulo 14049-900, Brazil;1. DynaLIFE Medical Labs and University of Alberta Department of Laboratory Medicine and Pathology, Edmonton, AB, Canada;2. St Michael’s Hospital and University of Toronto Department of Medicine, Toronto, ON, Canada;3. Sunnybrook Hospital and University of Toronto Department of Laboratory Medicine and Pathobiology, Toronto, ON, Canada;4. St Michael’s Hospital and University of Toronto Department of Laboratory Medicine and Pathobiology, Toronto, ON, Canada |
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| Abstract: | BackgroundSerum free light chain (FLC) analysis has been incorporated into the International Myeloma Working Group guidelines for the diagnosis and management of all monoclonal gammopathies. These recommendations were solely based on a single assay method (Freelite assay) and instrument. Here, we establish new reference intervals (RIs) for kappa and lambda FLC and the kappa-lambda difference and sum and a new diagnostic range for kappa/lambda FLC ratio (K/L-FLC) in an Optilite turbidimeter (The Binding Site) with the Freelite assay.MethodsTo establish new RIs, the CLSI EP28-A3C protocol was applied to 249 sample blood donors from Fuenlabrada, Spain, and the central 95% and total range were estimated. Samples from patients with polyclonal hypo- and hypergammaglobulinemia were used for the evaluation of K/L-FLC as a monoclonal proliferation index.ResultsThe new RIs and the new K/L-FLC diagnostic range for the Optilite (0.65–2.56 mg/L) are very different from those in on the guidelines (0.26–1.65 mg/L). We propose new RIs for the K − L difference and the K + L sum. Diagnostic range validation as a monoclonal proliferation index with samples with hypo- and hypergammaglobulinemia confirms this new range.ConclusionsIn this study, we present the FLC RI for Freelite reagents measured on an Optilite turbidimeter. These ranges are different from those provided by the manufacturer and from those used in most studies in the literature, which may lead to patient misclassification. Manufacturers and clinical laboratories must strive to provide RIs for the technology they are using and for their population. |
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| Keywords: | Reference interval Multiple myeloma Serum free light chain Monoclonal gammopathy Freelite |
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