Performance evaluation of a new high throughput Mindray BS-2000M1 clinical chemistry system.

Objective: To evaluate the photometry technical and analytical performance of a newly launched Mindray BS-2000M1 clinical chemistry system (BS-2000M1).

Design And Methods: The photometric parameters were evaluated according to the China Food and Drug Administration (CFDA) Automatic Chemistry Analyzer Guideline. The precision, accuracy, linearity and interference were evaluated according to CLSI protocols EP5-A2, EP9-A2, EP6-A and EP7-A2 respectively. The trueness verification on Ca(2+), Mg(2+), P(-) and Cl(-) was conducted by comparing with the reference methods using fresh samples.

Results: The photometer accuracy, precision, linearity, stability and stray light at 340 nm were acceptable. The within-run coefficients of variation (CVs) ranged from 0.16% to 2.13% and the total CV ranged from 0.64% to 4.12%. A good correlation (R>0.95) of method comparison between BS-2000M1 and our reference system was observed for most of the parameters tested with exception of Ca(2+) (R=0.85), Mg(2+) (R=0.71), P(-) (R=0.96, Slope=0.88), Cl(-) (R=0.93), and ASO (R=0.94, Slope=0.93, intercept=-8.81). The trueness verification on Ca(2+), Mg(2+), P(-) and Cl(-) showed acceptable results on both BS-2000M1 and our reference systems. Linearity study showed acceptable linearity range for all parameters. Significant interferences occurred for some evaluated parameters, but were identical to the manufacturer statement.

Conclusions: Mindray BS-2000M1 achieved the desirable photometry technical and analytical performance, and is therefore suitable for its utilization in modern clinical laboratories.