CAJ | 학술논문

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。
목적：평고아배ARCHITECT I2000SR화학발광의CEA잔여시제재이용적성능。방법회수합병잔여시제，평개기검측정밀도화회수솔，병의거미국림상실험실표준화위원회（NCCLS）EP9-A2문건방안，여원장시제진행대비시험。결과잔여시제검측CEA적비내정밀도2.84％～3.69％，천간정밀도3.28～4.86％，회수솔위92.31％～104.53％，균부합상관규정；량충시제검측CEA적상관계수r=0.996，회귀방정위Y=1.049X-0.521，재각의학결정수평（Xc）적예기편의（Bc）재윤허편의내，량방법상당，가이피접수。결론아배ARCHITECT I2000SR화학발광의CEA잔여시제적성능부합림상요구，가이회수재이용。
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.