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Serum Free Light Chain Quantification Testing: Comparison of Two Methods for Disease Monitoring?

机译:血清游离轻链定量检测:两种疾病监测方法的比较?

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Abstract Background Levels of free immunoglobulin light chains in serum and urine are a sensitive measure of dysregulated immunoglobulin synthesis. The development of an assay for free light chains in serum was a major advance in laboratory testing for monoclonal gammopathies. The original assay by The Binding Site, called Freelite?, has been in common use in laboratory monitoring of monoclonal gammopathies. Two clinical entities, myeloma-defining condition and light chain-predominant multiple myeloma, rely on quantitative measurements of serum free light chains.Methods Using polyclonal antisera specific to free light chains, Diazyme Laboratories developed a latex immunoturbidimetric assay for quantification of human kappa and lambda serum free light chains. We evaluated the Diazyme assay by comparing the results of kappa and lambda free light chain quantification, and kappa/lambda ratio with the results on the same specimens by the Freelite method. We also compared the correlation of the 2 methods to evaluate response to treatment and to changes in clinical status of patients with multiple myeloma.Results The results of Freelite and Diazyme methods are comparable. There was no statistically significant difference in the performance of the 2 assays for quantification of light chains, kappa/lambda ratio, or correlation of clinical parameters from patients with multiple myeloma at various stages of monitoring the disease in 2 geographically diverse laboratory and clinical environments.Conclusions The Diazyme method is comparable to Freelite and provides an opportunity to add the test to front-end automation and improvement in efficiency of the assay.
机译:抽象背景水平的免费的免疫球蛋白轻链在血清和尿液是敏感的免疫球蛋白合成特异表达。免费的发展分析轻链在实验室血清是一个重大进步检测单克隆丙种球蛋白病。分析的结合位点,称为Freelite吗?在实验室常用的监测单克隆丙种球蛋白病。myeloma-defining条件和光chain-predominant多发性骨髓瘤,依赖定量测量的无血清的光链。免费的光链,Diazyme实验室开发了一种乳胶immunoturbidimetric化验量化人力卡帕和λ血清免费的光链。通过比较卡帕和λ自由的结果轻链量化和k /λ比结果在同一标本Freelite方法。相关的方法来评估响应治疗和临床状态的变化多发性骨髓瘤患者。Freelite和Diazyme方法的结果具有可比性。显著差异的表现2分析量化的光链,kappa /λ比率,或相关的临床参数从多发性骨髓瘤患者监测疾病的不同阶段2地理上不同的实验室和临床环境。与Freelite和提供了一个将测试添加到前端的机会自动化和提高效率的化验。

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