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

Abstract

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