CAJ | 학술논문

目的：：对COBAS 8000生化分析仪的主要性能进行评价。方法：采用美国临床和实验室标准化协会的评价方法,对丙氨酸氨基转移酶、天冬氨酸氨基转移酶、碱性磷酸酶、总蛋白、白蛋白、葡萄糖、尿酸、肌酐对COBAS 8000生化分析仪的精密度、准确度和线性以及不同单元之间的差别进行比较。结果：COBAS 8000生化分析仪精密度均符合国家标准：批内精密度为0.994％~3.042％,批间精密度为1.374％~4.248％；在准确度实验中,8个项目的相对偏倚(1.05％~4.88％)均符合国家卫生标准要求；线性试验结果显示8项生化指标的线性理想(r2>0.95)；在不同单元的比对实验中,8个项目测定结果的差异均无统计学意义(P>0.05)。结论：COBAS 8000生化分析仪精密度、准确度和线性以及不同单元之间的差别测试均符合临床生化实验室评价要求,完全满足临床需要。
목적：：대COBAS 8000생화분석의적주요성능진행평개。방법：채용미국림상화실험실표준화협회적평개방법,대병안산안기전이매、천동안산안기전이매、감성린산매、총단백、백단백、포도당、뇨산、기항대COBAS 8000생화분석의적정밀도、준학도화선성이급불동단원지간적차별진행비교。결과：COBAS 8000생화분석의정밀도균부합국가표준：비내정밀도위0.994％~3.042％,비간정밀도위1.374％~4.248％；재준학도실험중,8개항목적상대편의(1.05％~4.88％)균부합국가위생표준요구；선성시험결과현시8항생화지표적선성이상(r2>0.95)；재불동단원적비대실험중,8개항목측정결과적차이균무통계학의의(P>0.05)。결론：COBAS 8000생화분석의정밀도、준학도화선성이급불동단원지간적차별측시균부합림상생화실험실평개요구,완전만족림상수요。
Objective:To evaluate the major performance of the biochemistry analyzer-COBAS 8000. Methods:The accuracy and precision of AST,ALT,ALP,TP,ALB,GLU,UA and Cr levels detected by COBAS 8000,and its linearity and difference comparision of different items were evaluated using the evaluation method of the American association of clinical and laboratory standards. Results:The precision of the COBAS 8000 accorded with the health standards. The precisions of within and inter-batch were 0. 994% to 3. 042%and 1. 374% to 4. 248%,respectively. During the accuracy test,the relative bias in 8 items(1. 05% to 4. 88%) were found,which accorded with the national health standards. The linearity results showed that the linearity of 8 biochemical indicators were ideal. During the different items comparision test,the differences of 8 items levels were not statistically significant(P >0. 05). Conclusions:The accuracy,precision,linearity and differences of different items of the biochemistry analyzer-COBAS 8000 accord with the evaluation requirement of clinical biochemistry laboratory.