K. Kaštylová, K. Černá, Š. Luxová, Petr Sebek, M. Lukáš
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引用次数: 0
摘要
研究目的:验证通过即时护理方法ProciseDx测量英夫利昔单抗和阿达木单抗浓度的结果是否与酶联免疫吸附试验(ELISA)测定的浓度相符。方法:比较23种英夫利昔单抗(IFX)和22种阿达木单抗(ADL)的浓度。采用基于Förster共振能量传递(FRET)原理的ProciseDx护理点(POCT)系统和临床实验室的标准免疫测定(ELISA)测量IFX和ADL谷水平。结果:IFX的Spearman相关系数R = 0.9400 (P = 0.0001),加权Cohen 's kappa为0.93,表明两种不同测量系统测量的数据具有良好的相关性。ADL也具有同样优秀的相关性,R = 0.9098 (P = 0.0001),加权Cohen 's kappa为0.834。结论:ProciseDx POCT系统是测定IBD患者血清IFX和ADL水平的一种高度可靠的方法。它操作简单、快捷,为IBD生物治疗带来了更大的效果,减少了IBD生物治疗的经济和时间负担。关键词:炎症性肠病,英夫利昔单抗,阿达木单抗,生物治疗,proaktivní terapeutick monitorování l iv, reaktivní terapeutick monitorování l iv,护理点监测
Point-of-care method for measuring infliximab and adalimumab trough levels in inflammatory bowel disease patients on biologic therapy
Aim of the study: To verify whether the results of infliximab and adalimumab concentration measurements by the point-of-care method ProciseDx correspond with the concentrations determined by enzyme-linked immunosorbent assay (ELISA). Methods: Twenty-three infliximab (IFX) and twenty-two adalimumab (ADL) concentrations were compared. IFX and ADL trough levels were measured by the ProciseDx point-of-care (POCT) system based on the Förster resonance energy transfer (FRET) principle, and by standard immunoassay (ELISA) in a clinical laboratory. Results: Spearman‘s correlation coefficient for IFX R = 0.9400 (P = 0.0001) and the weighted Cohen‘s kappa of 0.93 indicate a good correlation between data measured by two different measurement systems. The same excellent correlation of values was achieved for ADL, where R = 0.9098 (P = 0.0001) and the weighted Cohen‘s kappa is 0.834. Conclusion: The ProciseDx POCT system is a highly reliable method for measuring serum trough IFX and ADL levels in IBD patients. It is easy to operate and fast, it brings more effectiveness to the IBD biological treatment and reduces financial and time burden of this therapy. Keywords inflammatory bowel disease, infliximab, adalimumab, biologic therapy, proaktivní terapeutické monitorování léčiv, reaktivní terapeutické monitorování léčiv, point-of-care monitoring