Abstract
ObjectiveTo analyze the spectrum of abnormal serum free light chain ratio (sFLC κ/λ ratio), and to redefine the range of sFLC κ/λ ratio, so as to achieve hierarchical diagnosis of diseases with abnormal sFLC κ/λ ratio, resulting in the increased sensitivity and specificity in the diagnosis of monoclonal plasma diseases.MethodsEnrolled 1,340 patients with abnormal sFLC κ/λ ratio (<0.26 or >1.65) were grouped: (1) group A: malignant plasma diseases; (2) group B: monoclonal gammopathies of undetermined significance (MGUS); (3) group C: reactive plasma diseases. These patients were further divided by renal function eGFR <60 or >60 ml/min/1.73m2 to eliminate renal diseases influencing the results. Statistical analyses was performed by using SPSS 22 software.ResultsWhen sFLC κ/λ ratio >3.49 and eGFR >60ml/min/1.73m2, the sensitivity and specificity of the diagnosis of malignant plasma diseases were 86.1% and 94.0%, respectively. When sFLC κ/λ ratio >2.89 and eGFR <60ml/min/1.73m2, the sensitivity and specificity of the diagnosis of malignant plasma diseases were 92.0% and 97.0%, respectively.ConclusionThe sensitivity and specificity of the diagnosis of monoclonal plasma diseases can be significantly improved by redefining the cut-off value of sFLC κ/λ ratio and the renal function index of eGFR.
Highlights
Serum free light chain assay (Freelite) is an antibody-based system that measures kappa and lambda immunoglobulin light chains unbound to heavy chains in serum
The sensitivity and specificity of the diagnosis of monoclonal plasma diseases can be significantly improved by redefining the cut-off value of Serum free light chain (sFLC) κ/λ ratio and the renal function index of effective glomerular filtration rate (eGFR)
Among 4,786 patients accepted the sFCL assay in preliminary diagnosis, a total of 1,340 patients with combined abnormal sFLC ratio is screened out
Summary
Serum free light chain (sFLC) assay (Freelite) is an antibody-based system that measures kappa and lambda immunoglobulin light chains unbound to heavy chains in serum. In different clinical departments, when patients have different clinical manifestations, highly suspected or need to exclude monoclonal plasma diseases, the detection of serum free light chain (sFLC), serum protein electrophoresis (SPE) and serum immunofixation electrophoresis (sIFE) will be all completed. The monoclonal plasma diseases may have a variety of clinical manifestation, which may be shown as abnormal hemogram, nervous system disorder, cardiac muscle or www.impactjournals.com/oncotarget kidney amyloidosis and skeleton destroy, etc. The clinical physician would think that, the sFLC ratio anomaly normally prompts the monoclonal plasma diseases, especially when the M protein is detected as negative. It is of great importance to employ the sFLC assay to assist the diagnosis
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