A comparison between China-made Mindray BS-2000M biochemical analyzer and Roche cobas702 automatic biochemical analyzer

Objective

To assess the China-made equipment Mindray BS-2000M biochemical analyzer and explore the comparability between the results of the sixteen test parameters detected by Mindray BS-2000M biochemical analyzer and by imported equipment Roche cobas702 automatic biochemical analyzer.

Methods

In line with the American Clinical Laboratory Standardization Committee (NCCLS) document EP9-A2, Switzerland Roche cobas702 biochemical analyzer was used as a comparison system, while the Mindray BS-2000M served as an experimental system. Sixteen biochemical parameters from forty cases at different levels were tested at the same time. The correlation coefficient(r), linearity regression equation and absolute deviation (SE) and relative deviation (SE%) of test detection system (Y) and control detection system (X) at different medical decision levels were calculated. The clinical acceptability and comparability between different detection systems were tested according to the standard of allowed total error of American Clinical Proficiency Testing Laboratory Improvement Amendments (CLIA'88).

Results

The test results of the sixteen parameters between the two different biological detection systems were well-correlated (r² ≥0.95, p < 0.01). Linearity study showed acceptable linearity ranges for all the parameters. The relative deviation SE% of sixteen biochemical parameters at different medical decisions levels, excepting relative deviation of TP at two levels and TBIL at one level was greater than 1/2 CLIA 88 allowable total error, while the relative deviation or absolute deviation of the rest of the test parameters at their medical decision levels was less than 1/2CLIA88 predetermined allowable total error, and the total pass rate was 93%, so the China-made equipment Mindray BS-2000M biochemical analyzer may be clinically acceptable.

Conclusion

Mindray BS-2000M has achieved the desirable photometry technical and analytical performance, and can therefore be used in modern clinical laboratories.