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Assessment of the Performance of Cobas C501 Automatic Biochemical Analyzer

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  • Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China

Received date: 2013-09-14

  Revised date: 2013-10-22

  Online published: 2014-07-15

Abstract

Abstract:Objective To verify the precision, accuracy and linearity of Cobas C501 automatic biochemical analyzer by using total protein (TP) as a reference. Methods According to EP5-A2, EP6-A etc from Clinical and Laboratory Standards Institute (CLSI), TP was analyzed with Roche original reagent and calibrator to verify Cobas C501 automatic biochemical analyzer precision, accuracy and linearity. The EP evaluator software was applied for statistics analysis. Results In the 2 levels of TP, both of within standard deviation (SD) and total SD were less than verification value. The precision was acceptable. 20 specimens were measured by control instrument and experiment instrument; all of error indexes (EI) were in ±1.00 range. The accuracy verification passed. In linearity evaluation, the results of four of the five specimens over the reportable range were linear which indicating linearity was acceptable. Conclusion The precision, accuracy and linearity of TP detected by Cobas C501 system reach the performance that the manufacturer claimed.

Cite this article

ZHANG Li, CAI Juan, GUAN Xiao-yuan, Duan Bing, HUANG Yi-ling, ZHANG Bo, TIAN Lei, LI Yi-shi . Assessment of the Performance of Cobas C501 Automatic Biochemical Analyzer[J]. Labeled Immunoassays and Clinical Medicine, 2014 , 21(2) : 204 -207 . DOI: 10.11748/bjmy.issn.1006-1703.2014.02.028

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