CAJ | 학술논문

目的：对ADC CLIA 400全自动板式发光仪检测甲胎蛋白AFP和癌胚抗原CEA的方法学评价。方法按照美国临床实验室标准化委员会（CLSI）方法学评价系列文件，对 ADC电化学发光仪检测 AFP、CEA的批内精密度、批间精密度、分析测量线性范围和回收实验进行评价，并与厂商声明的性能和有关质量标准进行比较。结果该仪器批内精密度、批间精密度、分析测量线性范围和回收实验结果与厂商提供性能相符。结论 ADC400全自动板式发光免疫分析仪的主要分析性能符合质量目标要求，可满足临床检测需要。
목적：대ADC CLIA 400전자동판식발광의검측갑태단백AFP화암배항원CEA적방법학평개。방법안조미국림상실험실표준화위원회（CLSI）방법학평개계렬문건，대 ADC전화학발광의검측 AFP、CEA적비내정밀도、비간정밀도、분석측량선성범위화회수실험진행평개，병여엄상성명적성능화유관질량표준진행비교。결과해의기비내정밀도、비간정밀도、분석측량선성범위화회수실험결과여엄상제공성능상부。결론 ADC400전자동판식발광면역분석의적주요분석성능부합질량목표요구，가만족림상검측수요。
Objective To evaluate the performance of ADC CLIA 400 automatic plate luminescence to test al‐pha fetoprotein(AFP)and carcinoembryonic antigen(CEA)result .Methods The indexes of AFP ,CEA were detected according to the U .S .Committee for Standardization Clinical Laboratory (CLSI)methodology evaluated a series of documents .Results The instrument assay precision ,inter‐assay precision ,analytical measurement range of linear and recycling vendors accorded with the prescriptive range .Conclusion The performance of ADC CLIA 400 automatic plate luminescence is relable and suitable for clinical laboratory to use .