Ella和MSD分析仪检测细胞因子的性能比较

Performance Comparison of Ella and MSD Analyzers for Detecting Cytokines

目的:对Ella全自动微流控免疫分析仪(Ella)和MSD超敏电化学发光分析仪(MSD)测定细胞因子的分析性能进行验证及比较。方法:参照《中国药典》等相关法规,分别对Ella检测白细胞介素(IL)-1α、IL-1β、IL-6、IL-10、干扰素(IFN)-α、IFN-γ、C-X-C基序趋化因子10(CXCL10)、肿瘤坏死因子(TNF)-α,和MSD检测IFN-γ、IL-1β、IL-2、IL-4、IL-6、IL-8、IL-10、TNF-α的分析性能进行验证,运用SPSS软件对定量范围、精密度和准确度的结果进行比较。结果:两仪器定量范围分别是0.168~6630 pg/mL和0.244~1380 pg/mL,变异系数CV≤15.7%,相对误差RE在-20%~10%,均未发现基质效应,最大稀释倍数为256。相比之下,Ella定量范围和灵敏度优于MSD,精密度略劣于MSD,准确度两者差异不大。结论:Ella和MSD测定细胞因子的分析性能良好,可用于实验室相关检测。不同仪器检测同一因子的效果会略有差异,应根据待测物性质和仪器性能选择合适的方法。

Objective:To verify and compare the analytical performance of Ella automatic microfluidic immunoassay(Ella)and MSD hypersensitive electrochemiluminescence analyzer(MSD)for the determination of cytokines.Methods:Ella is used to detect interleukin(IL)-1α,IL-1β,IL-6,IL-10,interferon(IFN)-α,IFN-γ,C-X-C motif chemokine 10(CXCL10),tumor necrosis factor(TNF)-α,and MSD to detect IFN-γ,IL-1β,IL-2,IL-4,IL-6,IL-8,IL-10,TNF-α.According to Chinese Pharmacopoeia and other relevant regulations,the analytical performance of Ella and MSD is verified respectively,and SPSS software is used to compare the results of quantitative range,precision and accuracy.Results:The quantitative ranges of the two instruments are 0.168~6630 pg/mL and 0.244~1380 pg/mL respectively,the coefficient of variation CV≤15.7%,the relative error RE within-20%~10%,no matrix effect is found,and the maximum dilution ratio is 256.In contrast,the quantitative range and sensitivity of Ella are better than MSD,the precision is slightly worse than MSD,and the accuracy of the two instruments is not much different.Conclusion:The analysis performance of Ella and MSD for the determination of cytokines is good and can be used for laboratory correlation detection.The effect of different instruments to determine the same cytokines will be slightly different,and the appropriate method should be selected according to the properties of the sample to be measured and the performance of the instrument.