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.
题目: 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.
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Passing-Bablok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。.