Cobas 6000自动生化分析仪临床检验性能评价

Evaluation of performance of Cobas6000 automatic biochemical analyzer in clinical test.

目的:对Cobas6000自动生化分析仪在临床生化检验中的应用效果做出总体评价。方法:检测了质控血清、样本血清中的丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、总蛋白(TP)、白蛋白(ALB)、总胆红素(TB)、血糖(Glu)、尿素氮(Bun)、肌酐(Crea)、尿酸(Uric)、肌酸激酶(CK)、钾(K)、钠(Na)、氯(Cl)、钙(Ca)等项目;考察了精密度、线性相关性和回收入率,并与Vitros 950干化学全自动生化分析仪做了相关性分析。结果:批内变异系数为0.61%～2.36%,批间变异系数为0.81%～4.54%;标本的稀释度与测定的浓度值线性相关性较好;Cobas6000的测定结果与强生Vitros950相比,具有良好的相关性,相关系数r^2在0.9624～0.9975之间;回收率为95%～105%。结论:该仪器对血清各项生化指标的测定结果稳定,精密度和准确度均较好。

Objectives： To evaluate the performance of Cobas6000 automatic biochemical analyzer in its applications in clinical biochemical test. Methods： Fourteen items （ALT, AST, TP, ALB, TB, Glu, Bun, Crea, Uric, CK, K, Na, C1 and Ca） in quality-control serum and eight items （ALT, AST, TB, Glu, Bun, Crea, Uric and CK） in sample serum were tested. The precision （within-day CV and between-day CV）, linearity and recovery of measurement were studied. The results were compared with those of Vitros 950 analyzer. Results： within-day CV was 0.61%～2.36% and between-day CV was 0.81%～4.54%. There was good linear relationship between the dilution degree of sample and the measured concentration. The recovery was between 95 % to 105%. The test results of Cobas6000 and Vitros 950 have good correlationship （r2 =0. 9624-0. 9975）. Conclusion： The Cobas6000 analyzer are stable, precise and accurate.