不同血清游离轻链检测系统在多发性骨髓瘤疾病诊断中的比较分析  

Two Serum Free Light Chain Detection Systems in the Diagnosis of Multiple Myeloma

作　　者：朱国庆 付雪 任彦松 王艳生 王守磊 王立成 林筠 安刚 ZHU Guo-Qing;FU Xue;REN Yan-Song;WANG Yan-Sheng;WANG Shou-Lei;WANG Li-Cheng;LIN Jun;AN Gang(State Key Laboratory of Experimental Hematology,National Clinical Research Center for Blood Diseases,Institute of Hematology&Blood Diseases Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Tianjin 300020,China)

机构地区：[1]中国医学科学院血液病医院(中国医学科学院血液学研究所),实验血液学国家重点实验室,国家血液系统疾病临床医学研究中心,天津300020

出　　处：《中国实验血液学杂志》2021年第4期1209-1215,共7页Journal of Experimental Hematology

摘　　要：目的:观察Freelite, Binding Site,Beckman和N Latex FLC,Siemens这两种检测系统测定多发性骨髓瘤患者血清游离轻链结果的可比性。方法:选取2019年11月至2020年2月在中国医学科学院血液病医院初次诊断为多发性骨髓瘤的患者50例。采用两种检测系统(Freelite,Binding Site,Beckman和N Latex FLC,Siemens)对选取的分析样品进行血清游离轻链检测。同时,比较分析两种仪器血清游离轻链的检测结果,用ESD法进行离群值检测,用PassingBablok回归及Bland-Altman进行方法学比较及偏移评估。结果:两种系统对游离kappa轻链血清样品和游离lambda轻链样品均有定量分析。Freelite,Binding Site,Beckman和N Latex FLC,Siemens游离轻链检测结果分别为FLC-κ:36.5(6.5,194)、40.5(6.94,288),FLC-λ:30.1(4.3,170.5)、35.1(2.28,526),rFLC(FLC-κ/FLC-λ):0.82(0.05,43.25)、1.03(0.03,32.04),dFLC(|FLC-κ-FLC-λ|):-5.8(-161.97,183.7)、1.1(-505.1,279.01)。无离群值存在,有系统差异,偏移水平不在临床可接受范围内。结论:两种系统在临床应用均可满足诊疗需求,但两种系统测得的结果存在明显偏移,不具有可比性,不能交替使用、统一分析,尤其是在预后监测过程中更应该选择同一种系统进行检测。Objective: To investigate the comparability of the Freelite, Binding Site, Beckman and N Latex FLC,Siemens in the detection of serum free light chain(sFLC). Methods: Fifty newly diagnosed multiple myeloma(MM)patients in Tianjin Institute of Blood Research from November 2019 to February 2020 were enrolled. The two systems(Freelite, Binding Site, Beckman and N Latex FLC, Siemens) were used to detect the sFLC of the samples. Outlier detection was performed by ESD method, methodological comparison and deviation assessment were performed by Passing-Bablok regression and Bland-Altman regression. Results: Both the systems could quantitatively analyze free kappa light chain serum samples and free lambda light chain samples. Freelite, Binding Site, Beckman and N Latex FLC, Siemens free light chain test showed FLC-κ:36.5(6.5, 194), 40.5(6.94, 288), FLC-λ: 30.1(4.3, 170.5), 35.1(2.28, 526), rFLC(FLC-κ/FLC-λ) : 0.82(0.05, 43.25), 1.03(0.03, 32.04), dFLC(|FLC-κ-FLC-λ|) :-5.8(-161.97,183.7), 1.1(-505.1, 279.01), which existed no outliers. There were systematic differences, and the deviation level was not within the clinically acceptable range. Conclusion: Both the systems can meet the needs of clinical diagnosis and treatment, but there is a significant deviation between the two systems, the results are not comparable, and should be analyzed separately. In particular, the same system should be selected for monitoring the prognosis of MM.

关 键 词：血清游离轻链 多发性骨髓瘤 EP9-A3指南 

分 类 号：R733.3[医药卫生—肿瘤]