Performance evaluation of cobas pure integrated solutions at multiple sites in Europe and Asia

Abstract Objectives We evaluated analytical performance, functionality, reliability, and comparability of cobas ® pure integrated solutions (Roche Diagnostics) under routine-like conditions. Methods The study was conducted in Europe Asia (five sites). Seventy-six applications covering ion selective electrolytes (ISE), clinical chemistry (CC), immunochemistry (IC) analytes were assessed using Elecsys assays Diagnostics). Samples included control material pseudonymized residual samples (plasma/serum/urine). Analytical system reliability evaluated. An inter-laboratory survey, routine simulation imprecision (RSI) method comparison experiments, dedicated workflow runs conducted. Results Most coefficients variation (CVs) for repeatability <1 % ISE, ≤2 CC, <2.5 IC assays; intermediate precision ISE reproducibility ≤3 assays. RSI reference (94 %) random part (93 CVs %; 99 completed without system-related interruption. 218 comparisons generated median Passing–Bablok slope 1.00, bias at the medical decision point −0.1 %, Pearson’s r 0.998. Conclusions demonstrated precise accurate results conditions comparable vs. commercial analyzers, supporting implementation into practice.