Performance verification on ROCHE cobas 8000 automatic biochemical analyzer
10.3969/j.issn.1673-4130.2014.16.050
- VernacularTitle:罗氏 cobas 8000全自动生化分析仪的性能验证
- Author:
Xu MEI
;
Zheng LIU
;
Guangbin QIU
- Publication Type:Journal Article
- Keywords:
verification;
precision;
accuracy;
linear range;
reference interval
- From:
International Journal of Laboratory Medicine
2014;(16):2235-2236
- CountryChina
- Language:Chinese
-
Abstract:
Objective To verify the analytical performance of the Roche cobas 8000 automatic biochemical analyzer.Methods The intra-batch and inter-batch precisions,accuracy,linearity and reference interval were validated according to the Clinical and La-boratory Standards Institute (CLSI)documents (EP5-A2,EP15-A2,EP6-A;C28-A2 ).Results The intra-batch precision was 0.5%-2.3% and the inter-batch precision was 0.8%-3.11%,which were all less than 1/4 Tea(CLIA'88).The detection results of various items had better correlation with the target values(r2 >0.99);the linear range of various detected items were in line with the linear range provided by the specification;the quotative biological reference range conformed to the group of this laboratory services.Conclusion The various performance indexes of the Roche cobas 8000 automatic biochemical analyzer conform to the qual-ity requirements and this analyzer can be used in clinical biochemical detection work..
