Analytical performance evaluation of the Biosystems BA400 Clinical Chemistry Analyzer

Introduction: BA400 (Biosystems, Spain) is a new clinical chemistry analyzer for spectrophotometric, tubidimetric and ion-selective determination of biochemical analytes. Validation of method performance before routine operation is needed. Objective: The objective of this study was to perform the analytical evaluation of BA400 analyzer. Materials and methods: The evaluation was performed according to the guidelines of Clinical Laboratory Improvement Amendments (CLIA). The evaluation included determination of within-run and between-run imprecision, linearity and method comparison with Cobas 6000 (Roche). The 39 test analytes including metabolites, enzymes, trace elements, proteins and electrolytes were evaluated. Results: All analytes met the required specifications for imprecision except opiates, amphetamines and Phenytoin. The result showed acceptable inaccuracy for all analytes except cholinesterase, AST, microalbumin and valproic acid. The linearity was in acceptable ranges for all analytes. Conclusions: BA400 analyzer has satisfactory accuracy, precision and linearity for majority of analytes. However, some analytes require more study and adjustment for routine operation. Bull Chiang Mai Assoc Med Sci 2015; 48(1): 34-48. Doi: 10.14456/jams.2015.2