雅培ARCHITECT I2000SR化学发光CEA残余试剂再利用评估

摘要

Objective To evaluate the performance of recycling about CEA residual reagent in Abbott ARCHITECT I2000SR. Methods Recycle combined residual reagents, to evaluate the detection precision and recovery, and in accordance with the Committee of Clinical Laboratory Standards (NCCLS) EP9-A2 document solutions, comparative tests with the original reagents. Results The residual reagent CEA batch precision is 2.84%-3.69%, inter-day precision is 3.28%-4.86%, the recovery rate is 92.31%-104.53%, are in line with the relevant provisions; the two reagent CEA correlation coefficient r=0.996, the regression equation is Y=1.049X-0.521.The expected bias (Bc) was within allowed bias on the medical decision level (Xc), so two methods can be accepted. Conclusion About Abbott Architect i2000SR, the performance of CEA residual reagents accords with clinical requirement and can be recycled.%目的：评估雅培ARCHITECT I2000SR化学发光仪CEA残余试剂再利用的性能。方法回收合并残余试剂，评价其检测精密度和回收率，并依据美国临床实验室标准化委员会（NCCLS）EP9-A2文件方案，与原装试剂进行对比试验。结果残余试剂检测CEA的批内精密度2.84％～3.69％，天间精密度3.28～4.86％，回收率为92.31％～104.53％，均符合相关规定；两种试剂检测CEA的相关系数r=0.996，回归方程为Y=1.049X-0.521，在各医学决定水平（Xc）的预期偏倚（Bc）在允许偏倚内，两方法相当，可以被接受。结论雅培ARCHITECT I2000SR化学发光仪CEA残余试剂的性能符合临床要求，可以回收再利用。