Abstract：
OBJECTIVE: To observe the comparability of serum-free light chain (sFLC) detected by Beckman, Siemens, and Binding Site.
METHODS: In this study, 110 patients who were diagnosed with multiple myeloma in State Key Laboratory of Experimental Hematology from November 2019 to August 2020. According to the instructions of equipment and reagent manufacturers, three detection systems (Binding Site, Beckman, and Siemens) were used to detect the serum-free light chain of selected analysis samples. Meanwhile, sFLC test results of the three instruments were compared. According to EP9-A3 guide, correlation and consistency were conducted by Bland-Altman and Passing-Bablok regression.
RESULTS: The free kappa light-chain serum samples and the free lambda light-chain samples were quantitatively analyzed by the three systems. Binding Site, Beckman, and Siemens free light-chain detection results were as follows: FLC-κ: 42.23 (3.73, 423), 34.55 (6.5, 194), 39.85 (3.73, 423); FLC-λ: 31.46 (1.39, 8180.42), 32 (4.3, 275), 37.65 (2.28, 526); rFLC (FLC-κ/FLC-λ): 1.21 (0, 131.28), 0.96 (0.02, 43.49), 1.04 (0.04, 40.29). The Kappa valuation of FLC-κ between Beckman and Binding Site is 0.97, Kappa valuation of FLC-λ between Beckman and Binding Site is 0.96, Kappa valuation of rFLC between Beckman and Binding Site is 0.97. The Kappa valuation of FLC-κ between Siemens and Binding Site is 0.96, Kappa valuation of FLC-λ between Siemens and Binding Site is 0.88, Kappa valuation of rFLC between Siemens and Binding Site is 0.94.
CONCLUSIONS: All of the three systems can meet the needs of diagnosis and treatment in clinical application. These analyses showed a very good concordance between Beckman, Siemens, and Binding Site.
METHODS: In this study, 110 patients who were diagnosed with multiple myeloma in State Key Laboratory of Experimental Hematology from November 2019 to August 2020. According to the instructions of equipment and reagent manufacturers, three detection systems (Binding Site, Beckman, and Siemens) were used to detect the serum-free light chain of selected analysis samples. Meanwhile, sFLC test results of the three instruments were compared. According to EP9-A3 guide, correlation and consistency were conducted by Bland-Altman and Passing-Bablok regression.
RESULTS: The free kappa light-chain serum samples and the free lambda light-chain samples were quantitatively analyzed by the three systems. Binding Site, Beckman, and Siemens free light-chain detection results were as follows: FLC-κ: 42.23 (3.73, 423), 34.55 (6.5, 194), 39.85 (3.73, 423); FLC-λ: 31.46 (1.39, 8180.42), 32 (4.3, 275), 37.65 (2.28, 526); rFLC (FLC-κ/FLC-λ): 1.21 (0, 131.28), 0.96 (0.02, 43.49), 1.04 (0.04, 40.29). The Kappa valuation of FLC-κ between Beckman and Binding Site is 0.97, Kappa valuation of FLC-λ between Beckman and Binding Site is 0.96, Kappa valuation of rFLC between Beckman and Binding Site is 0.97. The Kappa valuation of FLC-κ between Siemens and Binding Site is 0.96, Kappa valuation of FLC-λ between Siemens and Binding Site is 0.88, Kappa valuation of rFLC between Siemens and Binding Site is 0.94.
CONCLUSIONS: All of the three systems can meet the needs of diagnosis and treatment in clinical application. These analyses showed a very good concordance between Beckman, Siemens, and Binding Site.
摘要：
目的：观察Beckman检测的无血清轻链（sFLC）的可比性，西门子,和绑定站点。
方法：在本研究中，2019年11月至2020年8月在实验血液学国家重点实验室诊断为多发性骨髓瘤的患者110例。根据设备和试剂制造商的说明，三个检测系统(结合位点，贝克曼,和Siemens)用于检测所选分析样品的无血清轻链。同时,对三种仪器的sFLC测试结果进行了比较。根据EP9-A3指南，用Bland-Altman和Passing-Bablok回归进行相关性和一致性。
结果：通过三种系统对游离κ轻链血清样品和游离λ轻链样品进行定量分析。绑定站点,贝克曼,西门子游离轻链检测结果如下:FLC-κ:42.23(3.73,423),34.55(6.5,194),39.85（3.73，423）；FLC-λ：31.46（1.39，8180.42），32(4.3,275),37.65（2.28，526）；rFLC（FLC-κ/FLC-λ）：1.21（0，131.28），0.96（0.02，43.49），1.04（0.04，40.29）。Beckman与结合位点之间的FLC-κ的Kappa估值为0.97,Beckman与结合位点之间的FLC-λ的Kappa估值为0.96,Beckman与结合位点之间的rFLC的Kappa估值为0.97。西门子与结合位点之间FLC-κ的Kappa估值为0.96,西门子与结合位点之间FLC-λ的Kappa估值为0.88,西门子与结合位点之间rFLC的Kappa估值为0.94。
结论：三种系统均能满足临床诊断和治疗的需要。这些分析表明贝克曼之间有很好的一致性，西门子,和绑定站点。
方法：在本研究中，2019年11月至2020年8月在实验血液学国家重点实验室诊断为多发性骨髓瘤的患者110例。根据设备和试剂制造商的说明，三个检测系统(结合位点，贝克曼,和Siemens)用于检测所选分析样品的无血清轻链。同时,对三种仪器的sFLC测试结果进行了比较。根据EP9-A3指南，用Bland-Altman和Passing-Bablok回归进行相关性和一致性。
结果：通过三种系统对游离κ轻链血清样品和游离λ轻链样品进行定量分析。绑定站点,贝克曼,西门子游离轻链检测结果如下:FLC-κ:42.23(3.73,423),34.55(6.5,194),39.85（3.73，423）；FLC-λ：31.46（1.39，8180.42），32(4.3,275),37.65（2.28，526）；rFLC（FLC-κ/FLC-λ）：1.21（0，131.28），0.96（0.02，43.49），1.04（0.04，40.29）。Beckman与结合位点之间的FLC-κ的Kappa估值为0.97,Beckman与结合位点之间的FLC-λ的Kappa估值为0.96,Beckman与结合位点之间的rFLC的Kappa估值为0.97。西门子与结合位点之间FLC-κ的Kappa估值为0.96,西门子与结合位点之间FLC-λ的Kappa估值为0.88,西门子与结合位点之间rFLC的Kappa估值为0.94。
结论：三种系统均能满足临床诊断和治疗的需要。这些分析表明贝克曼之间有很好的一致性，西门子,和绑定站点。
