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Reference change values of M-protein,free light chain and immunoglobulins in monoclonal gammopathy
Institution:1. Institute of Molecular Pathobiochemistry, Experimental Gene Therapy and Clinical Chemistry (IFMPEGKC), RWTH University Hospital Aachen, D-52074 Aachen, Germany;2. Laboratory Diagnostic Center, RWTH University Hospital Aachen, D-52074 Aachen, Germany;1. Department of Hematology, Odense University Hospital, Klovervaenget 10, 12th floor, 5000 Odense C, Denmark;2. Department of Hematology, Odense University Hospital, Denmark;1. Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, Alberta, Canada;2. DynaLIFE Medical Laboratories, Edmonton, Alberta T5J 5E2, Canada;1. Department of Biochemistry and Pharmaco-Toxicology, University Hospital of Brest, Brest, France;2. Univ Brest, LIEN, F-29200 Brest, France;1. University of Toronto, Toronto, ON, Canada;2. William Osler Health System, Brampton, ON, Canada,;3. Hamilton Health Sciences, Hamilton, ON, Canada;4. McMaster University, Hamilton, ON, Canada;1. Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, Alberta, Canada;2. MEDICAL LABS;3. Division of Hematology, Department of Medicine, Faculty of Medicine, University of Alberta, Edmonton, Canada;4. Alberta Health Services, Edmonton, Canada;1. SC Analisi Chimico Cliniche, Ospedale di Desio, Via Mazzini 1, 20832 Desio, Italy;2. Dipartimento Medicina-Chirurgia, Università Milano Bicocca, Via Cadore 48, 20900 Monza, Italy;3. Genetics Unit, ASST Lariana, via Ravona 20, 22020 San Fermo della Battaglia, Como, Italy
Abstract:ObjectivesClinical decisions in patients with monoclonal gammopathies may be highly imprecise because of variations of parameters used in diagnosis. In this study, we aimed to calculate the variation in M-protein, free light chains (FLCs), and immunoglobulins in respective patients.Design & methodsWe analyzed the data of clinically stable patients with monoclonal gammopathy (MG), which were monitored for 7-years to determine the biological variations and reference change values (RCV) of serum M-protein, monoclonal serum FLCs and immunoglobulin (Ig) concentrations. Patients that were included in the study had no change in diagnosis and showed <5 g/L change in serum M-protein during the monitoring. From the patients included at least 3 consecutive samples were analyzed within 8 months and 7 years of initial diagnosis.ResultsThe total coefficient of variations (CV) was calculated for M-protein and involved/uninvolved fractions of FLCs and immunoglobulins. From 38 patients and 456 samples that were included in the study, the total CVs were calculated for serial M-proteins (8.9%), serum involved FLCs (iFLC, 21.4%), involved Ig (i-Ig, 8.7%) and uninvolved Ig (u-Ig, 9.1%). Combining these CVs and the interassay analytical CVs, we calculated the biological CV for the serum M-protein (8.4%), serum iFLC concentration (21.1%), i-Ig (8.6%) and u-Ig (9.0%). A significant correlation was found in multiple myeloma patients between the κ/λ light chain ratio (rFLC) with i-Ig, the difference between i-Ig level and u-Ig level (d-Ig) and ratio Ig (r-Ig) (r = 0.790, 0.703 and 0.711, respectively). These correlations were not found in patients suffering from MG of undetermined significance and smoldering multiple myeloma.Conclusionsi-Ig determinations may be an alternative to M-protein for MGs. The variations in serum FLC measurements during MG monitoring were greater than those observed in serum M-proteins and therefore need to be more rigorously revised for recommendations.
Keywords:FLC  IgG  Immunoglobulin  M-protein  Monoclonal gammopathy  Multiple myeloma
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