Analytical performance evaluation of the mindray BS 430 clinical chemistry analyzer
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Abstract
The BS 430 analyzer from Mindray, China, is a newly released, low-cost automated clinical chemistry analyzer that is gaining popularity and is increasingly used in laboratories across Thailand. However, because it is manufactured by an Asian company, it may not be regarded with the same confidence as devices from traditional Western manufacturers. Therefore, it is important to evaluate its performance, since laboratory results must be accurate, precise, and reliable. The aim of this study was to evaluate the performance of the Mindray BS 430 automated clinical chemistry analyzer, including precision, accuracy, and evaluation of the reportable range of analysis, all in accordance with the guidelines of the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) standards. The precision assessment showed within-run precision (%CV) ranging from 0.49% to 3.34% and day-to-day precision (%CV) ranging from 2.40% to 6.81%. All tests met the specified criteria; however, three tests exhibited intermediate precision values higher than the allowed limits. With regard to accuracy, compared to the reference device (Cobas® pro Chemistry Analyzer), the correlation coefficient (r) ranged from 0.935 to 1.000, with three tests having an r value of less than 0.975. The evaluation of the reportable range from the linearity experiment showed a %bias for all items that did not exceed the Total Allowable Error (TEa). The study concluded that the Mindray BS 430 analyzer has adequate precision and accuracy for blood biochemical measurements in routine laboratory use. Some analytes require further investigation and adjustment before routine implementation. The study provides guidance for users in selecting an automated clinical chemistry analyzer to optimize their laboratory's effectiveness.
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