Performance evaluation between two automated biochemical analyzer systems: Roche Cobas 8000 and Mindray BS2000M

Abstract

Background: The values of biomarkers play a central role in routine clinical decision-making. Whereas the performance of different automated chemical analyzers remains unclear. To determine the performance of different platforms, we compared the consistency and accuracy between Roche Cobas 8000 and Mindray BS2000M. Methods: A total of 1869 remaining serum samples were collected. CK, LDH-1, RBP, Cys-C, IgA, IgM, and IgG were assessed using paired t-test, Passing-Bablok regression analysis, and Bland-Altman analysis according to CLSI EP5-A3. Results: There were significant differences in the average bias of all items between the two machines (P<0.001). Because the 95% confidence interval of intercept A included 0, CK, LDH-1, Cys-C and IgG did not show systematic error in Passing-Bablok regression analysis. The confidence interval of 95% of the slope B in IgM contained 1, and there was no difference in the two measurements in IgM. Except for IgA, the r values and correlation coefficient of all items were higher than 0.91, which showed that the correlation and consistency were good. The Bland-Altman analysis showed that two instruments had more than 95% of the points apart from CK, LDH-1, and IgA. Conclusions: It can be considered that the two instruments have good correlation and consistency in CK, LDH-1, RBP, Cys-C, IgM, and IgG, and the two instruments are interchangeable and can replace each other.

Keywords

• analytical techniques and equipment
• validation
• roche cobas 8000
• mindray bs2000m
• comparison