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

Area of Science:

• Clinical Chemistry
• Biomarker Analysis
• Medical Diagnostics

Background:

• Biomarker values are crucial for clinical decisions.
• The performance of automated chemical analyzers is not well-defined.
• This study compares the Roche Cobas 8000 and Mindray BS2000M platforms.

Purpose of the Study:

• To evaluate the consistency and accuracy of biomarker measurements between two automated platforms.
• To determine if the Roche Cobas 8000 and Mindray BS2000M are interchangeable for clinical use.

Main Methods:

• 1869 serum samples were analyzed.
• Biomarkers assessed include CK, LDH-1, RBP, Cys-C, IgA, IgM, and IgG.
• Statistical analyses included paired t-test, Passing-Bablok regression, and Bland-Altman analysis.

Main Results:

• Significant differences in average bias were observed between the two machines (P<0.001).
• CK, LDH-1, Cys-C, and IgG showed no systematic error; IgM showed no measurement difference.
• High correlation (r > 0.91) and consistency were found for most biomarkers, with Bland-Altman analysis supporting interchangeability for CK, LDH-1, RBP, Cys-C, IgM, and IgG.

Conclusions:

• The Roche Cobas 8000 and Mindray BS2000M demonstrate good correlation and consistency for CK, LDH-1, RBP, Cys-C, IgM, and IgG.
• These two automated analyzers are considered interchangeable for clinical applications.
• The findings support the use of either platform for routine biomarker assessment.