Roche-Hitachi cobas 8000 c702 자동화학분석기의 성능 평가
Performance Evaluation of the Roche-Hitachi cobas 8000 c702 Chemistry Autoanalyzer
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초록
배경: 최근 Roche-Hitachi사의 cobas 8000 c702는 화학과 면역검사를 통합할 수 있는 최신 시스템이다. 저자들은 상기 장비의 사용 시 생길 수 있는 시행착오를 예방하고 신뢰성 있는 결과를 얻기 위해 상기 장비의 유용성과 분석능력을 평가하고자 하였다. 방법: 일반화학 31 검사 항목에 대해 정밀도, 직선성, 검체 간 오염률과 기존 장비와의 상관성을 CLSI 지침에 따라 평가하였다. 정밀도 평가를 위해 상품화된 정도관리 물질인 Lyphocheck (Bio-Rad Laboratories Inc., USA) Level I, II를 사용하였고, 직선성 평가를 위해 위해 Validate (Marine Standard Company, USA)를 사용하였다. 기존 장비 Unicel DxC (Beckman Coulter, USA)와의 상관성 평가에는 환자 검체를 사용하였다. 결과: 일반화학 31 검사 항목 중 CO2와 ammonia를 제외한 검사종목의 총 정밀도는 0.4-4.1%였고, 모든 검사 항목은 임상적으로 중요한 범위에서 직선성을 나타내었다. Unicel DxC와의 상관성은 상관계수 0.921-1.000으로 우수하였고, 검체 간 교차오염률은 -0.216-0.481%였다. 결론: Roche-Hitachi 사의 cobas 8000 c702는 일반화학 검사 항목의 측정에서 우수한 정밀도, 직선성, 기존 장비와의 상관성을 보여주었고, 검체 간 교차오염률도 낮아 기기 성능이 만족할 만하였다. 결론적으로, 본 기기는 검사의 효율화와 정확성을 도모할 수 있으므로, 검사 건수가 많은 대형병원 검사실에 유용하게 사용될 수 있을 것임을 입증할 수 있었다.
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.
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