Performance Verification of the Detection of AFP and CEA in Roche Cobas 6 0 0 0 Automatic Electrochemical Luminescence Analyzer
10.3969/j.issn.1671-7414.2014.06.041
- VernacularTitle:罗氏Cobas 6000全自动电化学发光分析仪检测AFP，CEA的性能验证
- Author:
Li YANG
;
Yeli HE
;
Han WANG
;
Chengrong BIAN
;
Weidong WANG
;
Jun XU
;
Jia LIU
- Publication Type:Journal Article
- Keywords:
automatic electrochemical luminescence analyzer;
tumor marker;
performance verification
- From:
Journal of Modern Laboratory Medicine
2014;(6):127-130
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the performance verification of AFP and CEA detected by Roche Cobas 6000 automatic electrochemical luminescence analyzer.Methods Serum samples in hospital patients during April 1 to 4,2014 were collected and mixed.Samples with the different levels of AFP and CEA were prepared.Referring to CLSI EP files and other docu-ments,the precision,accuracy and the reported linear range of AFP and CEA from Roche Cobas 6000 automatic electrochem-ical luminescence analyzer were verified.Results AFP and CEA in the quality control sera with low and high values were detected by Roche Cobas 6000 automatic electrochemical luminescence analyzer.The coefficient of variations (CV)of inter batch precision were AFP (6.53%,8.38%),CEA (8.15%,7.84%),and the CV of within batch precision were AFP (3.97%,6.51%),CEA (4.77%,4.52%),respectively.10 copies of laboratory quality control were analyzed,issued by the National Center for clinical laboratory in 2013.The largest bias between detection results and“target value”were AFP (-12.62%)and CEA (-10.71%)respectively,which were all within the measurement range of quality assessment.Analysis of measuring range in the linear range experiment were AFP (0.5~1 000 IU/ml),CEA (0.2~1 000 ng/ml),and the clini-cal reportable range were AFP (0.5~1 000 IU/ml),CEA (0.2~1 000 ng/ml),respectively.Conclusion Detection of AFP and CEA from Roche Cobas 6000 automatic electrochemical luminescence analyzer had a good performance.Meanwhile,the Roche Cobas 6000 automatic electrochemical luminescence analyzer could meet the clinical routine testing requirements.
