Performance Evaluation of Roche Cobas e411 Electrochemical
Luminescence Automatic Immunoassay System
HU Haiyan1a, YIN Lijuan2, ZHANG Jing1a, FENG Tao1a, JIANG Chunlin1a, DU Shuang1b
1.a.Department of Clinical Laboratory; b.Department of Blood Transfusion, Xing’an League People’s Hospital of Inner Mongolia
Autonomous Region, Ulan Hot Inner Mongolia 137400, China; 2.Department of Clinical Laboratory, Harbin 242nd Hospital, Harbin
Heilongjiang 150060, China
Abstract:Objective This paper aims to evaluate and analyze the performance of Roche Cobas e411 electrochemical luminescence
full automatic immune system with β-HCG. Methods According to the clinical and laboratory standards institute (CLSI) file and the
People’s Republic of China health industry standard WS/T408-2012 linear evaluation guide clinical chemistry equipment, patients
serum, ventricular interstitial material and β-HCG were used to evaluate precision, accuracy, linear reportable range of this machine
by comparing the results of Roche Cobas e411 with reference instruments, in order to find whether they had the same results. Results
Mixed serum in patients was used to complete the β-HCG precision test, and results showed that total CV value and CV value within
the group were less than manufacturer statement CV value. External quality assessment was used to complete measurement accuracy
test, the bias between 5 quality assessment and return target value were all in the range of 9.8%~13.8%, which were all in the range
of external quality assessment. High value specimens which close to β-HCG superior limit were chosen to complete linear evaluation
experiment, results showed that the data set were in the range of 0.1~9572 mIU/mL, with clinical acceptable nonlinear. 20 patients’
specimens were selected to do comparison test, absolute bias of calculation and reference instruments were less than 12.5%, results
showed that the test was passed. Conclusion β-HCG tests in Roche Cobas e411 electrochemical luminescence full automatic immune
system show that precision and accuracy of the machine meet the requirements, and linear and reportable range are acceptable in clinical.