Performance evaluation of ROCHE COBAS INTEGRA 400 plus full-automatic biochemistry analyzer

Objective: To evaluation the main performance of ROCHE COBAS INTEGRA 400 plus full-automatic biochemistry analyzer. Methods: To evaluate the precision, accuracy, reportable range of ROCHE COBAS INTEGRA 400 plus full-automatic biochemistry analyzer by 6 items (AST, Glu, Crea, K+, Na+, Cl-) according to the NCCLS guidelines EP5-A2, EP6 and EP9. Results: The results of within-run CV, between-run CV and total CV in the precision evaluation experiments by using quality control serums were under the WHO OCV/RCV criterions and NCCL RCV criterions; The average bias of each testing items were 0.85%~4.55% in the accuracy evaluation experiments, which is under the NCCLS permitted bias; The reportable range of each testing items were close to the expected values; Estimate of repeatability of each testing items show good correlations (r0.975) and linearities. Conclusions: The main performance of precision, accuracy, reportable range of ROCHE COBAS INTEGRA 400 plus full-automatic biochemistry analyzer accord with the performance claims of clinical biochemical examination.