美国Abbott Axsym免疫分析仪性能初步评价

An Evaluation of the Main Performance of the Abbott Axsym System

目的 对Abbott Axsym免疫分析仪性能进行评价。方法 通过检测HBsAg,对Abbott Axsym免疫分析仪的灵敏度、特异性、正确检测率(可检测性)、重复性、线性及与ELISA检测HBsAg的相关性等指标进行测定。结果 Abbott Axsym免疫分析仪的灵敏度达到0.16μg/L,特异性为100％,正确检测率(可检测性)为99.72％,不同参比血清的总CV值在5.4％～9.4％之间波动,在0.1～100 μg/L范围内线性良好(r=0.994 9),与ELISA比较,两法的符合率为97％。结论 该仪器设计科学合理,检测快速方便,结果准确可靠,是大、中型医院临床实验室比较理想的免疫分析仪之一。

Objective To evaluate the performance of the Abbott Axsym system. Methods The sensitivity ,specificity de-tectablity,reproducibility .linearity .relativity with ELISA of the Abbott Axsym system was determined on the instrument by detecting HBsAg. Results The sensitivity .specificity .detect ablity of the Abbott Axsym system was 0. 16μg/L,100%, 99.7% respectively, and the total CV s was from 5. 4% to 9. 4% with varied referenced serum. The linearity of determining HBsAg on the instrument was satisfying(r= 0. 004 9) with the range of 0. 1-100μg/L,and the relativity was 97% in comparison with the ELISA. Conclusion The performance of the Abbott Axsym system is satisfactory .and it is one of the better immunology analyzer with wide-range linearity .high sensitivity and low CV s.