Performance verification of Roche COBAS 6000 automatic electrochemiluminescence immunoassay analyzer

Objective To test and verify the system performance of Roche COBAS 6000 automatic electrochemiluminescence immunoassay analyzer according to the requirements of ISO15189.Methods Verification experiments were taken to measure the precision,accuracy,clinical reportable range(CRR),analytical measurement range(AMR),reference interval of alpha-fetoprotein(AFP).Results The high and low values of coefficient variation(CV)of inter-assay were 3.28% and 3.46%,and those of between-day precision were 4.39% and 5.13%,which were all less than the CV provided by the manufacturer(10%).Relative bias was 0.862%.Analytical measurement range was 0.80-1 200 ng/ml,the reference interval was 0-20.00 ng/ml,and the clinical reportable range was 0-60 000 ng/ml.Conclusion The basic performances of Roche COBAS6000 automatic electrochemiluminescence immunoassay analyzer are consistent with the data provided by the manufacturer,so it can be used to inspect the clinical samples and the results are credible.