目的:对贝克曼IMMAGE800免疫化学分析仪测定风湿三项(抗链球菌溶血素O(ASO)、类风湿因子(RF)、C反应蛋白(CRP))血清指标进行初步评价。方法:通过速率散射比浊法对ASO、RF、CRP血清指标的精密度、正确度、线性、携带污染等指标进行检测,评价贝克曼IMMAGE800免疫化学分析仪检测系统的性能。结果:IMMAGE800免疫化学分析仪的批内精密度(低水平)ASO变异系数(CV)为5.97%,RF和CRP的标准差(SD)分别为2.324、0.411,批内精密度(高水平)变异系数(CV)分别为3.43%、2.29%、4.54%,批间精密度(低水平)变异系数(CV)分别为4.46%、4.48%、4.81%,批间精密度(高水平)变异系数(CV)分别为5.09%、4.97%、3.35%。ASO、RF、CRP检测的相对偏差均小于CLIA’88或PT能力验证允许误差的1/2。ASO、RF、CRP检测的线性回归系数(r2)分别为0.9773、0.9939、0.9982。CRP携带污染率为-0.0193%。结论:IMMAGE800免疫化学分析仪具有良好的精密度、正确度、重复性和线性、携带污染率小,符合要求。
Objective:To evaluate the method for ASO,RF,CRP detection with IMMAGE800 Immune chemical analyzer.Methods:Though the method of rate scattering turbidimetry to detect the precision, accuracy, linear, carry pollution index for ASO,RF,CRP,and to evaluate the method for ASO,RF,CRP detection with IMMAGE800 Immune chemical analyzer.Result:The intra assay coefficient of variation(CV) of ASO of low value was 5.97%, and the standard deviation (SD) of RF and CRP were 2.324,0.411. The intra assay coefficient of variation(CV) of high value were 3.43%,2.29%,4.54%. The inter assay coefficient of variation(CV) of low and high value were 4.46%,4.48%,4.81%,5.09%,4.97%,3.35%. The relative deviation was less than half of the permissible error,which CLIA 88 or PT were allowed. The linear regression coefficient (r2) were 0.9773, 0.9939, 0.9982, respectively.The carry pollution rate of CRP was -0.0193%. Conclusion:The IMMAGE800 Immune chemical analyzer has good precision, accuracy, linear and carr