【摘要】 目的评价i-CHROMATM READER免疫荧光分析仪的性能。方法根据文献自行设计方案,以C-反应蛋白(C-reactive protein,CRP)作为分析指标,对仪器的精密度、稳定性、线性、可比性及抗干扰能力等进行评价。结果批内和批间精密度分别为2.26%～2.94%和2.40%～3.33%,日间精密度3.59%～3.95%,稳定性实验48 h内CV%为2.90%,皆在厂家承诺的范围内;线性实验显示方程为y=1.021x-0.408,相关系数r=0.998;对比实验表明i-CHROMATMREAD-ER免疫荧光分析仪与Beckman Immage特定蛋白分析仪检测结果相关性良好(r=0.977),t=0.842,P>0.05,差异无统计学意义;黄疸和乳糜干扰物对测试结果的影响度分别为-3.4%～3.9%和-3.5～4.6%。结论该分析仪具有操作简单、检测速度快、精密度高、抗老化性能好、可比性高、抗干扰能力强等特点,适用于医院门、急诊、病房床旁以及社区医疗点。更多还原

【Abstract】 Objective To evaluate the performance of i-CHROMATMREADER fluorescence immunoassay analyzer.Methods CRP was chosen as the item to evaluate the precision,stability,linearity,comparability and anti-interfered ability of the analyzer according to CLSI.Results Coefficients of variation of the inter-batch testing,day precision testing and stability testing were 2.40%～3.33%,3.59%～3.95% and 2.90%,respectively,between the range supplied by the manufacturer.The practical value and the theoretical value detected by the analyzer had good linear relationship(r=0.998).The results tested by the analyzer showed no significant difference compared with those tested by the Beckman Immage specialized protein analyzer(P>0.05).The interference rate of TBIL and TG was-3.4%～3.9%,-3.5%～4.6%,respectively.Conclusion The analyzer is a POCT product suitable to out-patient,emergency and community medicine treatment.更多还原