Abstract
Abstract Background The precision of the new cobas® pro integrated solutions cobas® ISE neo and cobas c 703 analytical units (Roche Diagnostics International Ltd, Rotkreuz, Switzerland) was measured under intended use conditions in a routine simulation setting. Methods The interaction of hardware, software, assays, and samples was tested at two sites (Aalst, Belgium and Heidelberg, Germany) between October and December 2023. Reproducibility under various stressed routine-like conditions, including provocations, was tested using routine simulation imprecision experiments. To test the interaction of new and existing analytical units under routine conditions, test configurations including commercially available cobas c 503 and cobas e 801 analytical units were used. The first configuration comprised one cobas ISE neo analytical unit, two cobas c 703 analytical units, and one cobas e 801 analytical unit. The second configuration comprised one cobas ISE neo analytical unit, one cobas c 703 analytical unit, one cobas c 503 analytical unit, and one cobas e 801 analytical unit. The precision of batch type measurements was compared with the precision under routine simulated random access conditions. Random access coefficients of variance (CVs) that exceeded 1.5× reference batch CVs, or single measurements deviating by >10% from the batch mean, triggered in-depth analysis of the system components that contributed to the result. Results Overall, 56 applications were measured during the reference and random parts of seven routine simulation imprecision runs: six ion selective electrodes (ISE; three serum, three urine), 35 clinical chemistry applications on cobas c 703 (27 serum, eight urine), seven clinical chemistry applications on cobas c 503 (five serum, one urine, one whole blood) and eight immunochemistry (serum) applications. Of six ISE (serum and urine) applications, the mean reference and random CVs were 0.8% and 0.9%, respectively. Of 42 clinical chemistry (serum, urine, and whole blood) applications, the mean reference CV was 0.9% and the mean random CV was 1.0%. Of eight immunochemistry (serum only) applications, mean reference and random CVs were 1.1% and 1.4%, respectively. Conclusions The findings from this study demonstrate that the new cobas ISE neo and cobas c 703 analytical units show consistent results over a prolonged time period, with most CVs in this setting below 0.9%. These results also show the successful integration of the new analytical units into the cobas pro integrated solutions, with seamless interaction of existing and analytical units under stressed conditions.
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