cobas 8000 Modular analyzer series evaluated under routine-like conditions at 14 sites in Australia, Europe, and the United States.

Clinical laboratories need to test patient samples precisely, accurately, and efficiently. The latest member of the Roche cobas modular platform family, the cobas 8000 modular analyzer series allows compact and convenient consolidation of clinical chemistry and immunochemistry assays in high-workload laboratories with a throughput of 3 to 15 million tests annually. Here we present the results of studies designed to test the overall system performance under routine-like conditions that were conducted at 14 laboratories over 2 y. Experiments that test analytical performance of the new module were integrated with overall system functionality testing of all modules in different configurations. More than two million results were generated and evaluated for ~100 applications using serum/plasma, urine, or EDTA blood samples. During the workflow studies, eight configurations of the possible 38 combinations were used, covering all available analytical modules. The versatility of the module combinations makes the system customizable to fit the needs of diverse laboratories, allowing precise and accurate analysis of a broad spectrum of clinical chemistry and immunochemistry parameters with short turnaround times. This new system will contribute to the ability of clinical laboratories to offer better service to their customers and support vital clinical decision making.

Increasing Efficiency and Quality by Consolidation of Clinical Chemistry and Immunochemistry Systems with MODULAR ANALYTICS SWA.

MODULAR ANALYTICS Serum Work Area (in USA Integrated MODULAR ANALYTICS, MODULAR ANALYTICS is a trademark of a member of the Roche Group) represents a further approach to automation in the laboratory medicine. This instrument combines previously introduced modular systems for the clinical chemistry and immunochemistry laboratory and allows customised combinations for various laboratory workloads. Functionality, practicability, and workflow behaviour of MODULAR ANALYTICS Serum Work Area were evaluated in an international multicenter study at six laboratories. Across all experiments, 236000 results from 32400 samples were generated using 93 methods. Simulated routine testing which included provocation incidents and anomalous situations demonstrated good performance and full functionality. Heterogeneous immunoassays, performed on the E-module with the electrochemiluminescence technology, showed reproducibility at the same level of the general chemistry tests, which was well within the clinical demands. Sample carryover cannot occur due to intelligent sample processing. Workflow experiments for the various module combinations, with menus of about 50 assays, yielded mean sample processing times of <38 minutes for combined clinical chemistry and immunochemistry requests; <50 minutes including automatically repeated samples. MODULAR ANALYTICS Serum Work Area offered simplified workflow by combining various laboratory segments. It increased efficiency while maintaining or even improving quality of laboratory processes.

An innovative approach to functionality testing of analysers in the clinical laboratory.

The established protocols for evaluating new analytical systems produce indispensable information with regard to quality characteristics, but in general they fail to analyse the system performance under routine-like conditions. We describe a model which allows the testing of a new analytical system under conditions close to the routine in a controlled and systematic manner by using an appropriate software tool. Performing routine simulation experiments, either reflecting imprecision or method comparison characteristics, gives the user essential information on the overall system performance under real intended-use conditions.