Lab Med Online.  2014 Jul;4(3):132-139. 10.3343/lmo.2014.4.3.132.

Performance Evaluation of the Roche-Hitachi cobas 8000 c702 Chemistry Autoanalyzer

Affiliations
  • 1Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
  • 2Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea. wkmin@amc.seoul.kr

Abstract

BACKGROUND
Optimal operational efficiency requires specific technical solutions such as open, flexible, and adaptable space, suitable equipment requirements, and laboratory instrumentation that combine excellent analytical performance with a capacity for testing large panels in a high throughput manner, under rapid turnaround times. Thus, the aim of this study was to assess the analytical performance of the novel Roche-Hitachi cobas 8000 c702 Chemistry Autoanalyzer.
METHODS
Precision, linearity, carry over, detection limits, and comparison studies were performed with 31 routine clinical chemistry tests according to the CLSI guidelines. Commercial quality chemistry control material (Lyphochek, Bio-Rad, USA) and patient sera were used as the test specimens. Unicel DxC instrument (Beckman Coulter, USA) was used as a control analyzer to evaluate the correlation.
RESULTS
The total coefficients of variations (CVs) of almost all the analytes were between 0.4 and 4.1%, except for CO2 and ammonia. Excellent linearities were observed in the performance ranges used (r>0.99, slope, 0.961-1.048). Correlations with analogous tests ran on the Unicel DxC instrument were good, correlation coefficients ranging between 0.921 and 1.000. The carryover ranged from -0.216 to 0.481%.
CONCLUSIONS
The Roche-Hitachi cobas 8000 c702 Chemistry Autoanalyzer showed satisfactory precision, linearity, carry over, detection limits, and high throughput capacity. The instrument performance correlated well with the Unicel DxC analyzer. We conclude that the balance of elevated throughput and optimal analytical performance should make Roche-Hitachi cobas c702 Chemistry Autoanalyzer suitable for very large clinical laboratories.

Keyword

Analytical performance; Roche-Hitachi cobas 8000 c702; Evaluation
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