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Christian Bieglmayer, Daniel W. Chan, Lori Sokoll, Roland Imdahl, Masaji Kobayashi, Erike Yamada, Diana J. Lilje, Hilmar Luthe, Jochen Meissner, Gianni Messeri, Alessandra Celli, Paola Tozzi, Heinz-Jürgen Roth, Frank-Peter Schmidt, Marie-Luise Mächler, Pe
Multicentre performance evaluation of the E170 Module for MODULAR ANALYTICS
Keywords: immunoanalyser, performance evaluation, practicability, workflow
The E170 module was evaluated at 13 sites in an international multicentre study. The objective of the study was to assess the analytical performance of 49 analytes, and to collect feedback on the system’s reliability and practicability. The typical, within-run coefficients of variation (CVs) for most of the quantitative assays ranged between 1 and 2% while a range of 2–4% was achieved with the infectious disease methods. Total precision CVs were found to be within the manufacturer’s expected performance ranges, demonstrating good concordance of the system’s measuring channels and a high reproducibility during the 2–4-week trial period. The functional sensitivity of 11 selected assays met the clinical requirements (e.g., thyreotroponin (TSH) 0.008 mU/l, troponin T 0.02 µg/l, total prostate-specific antigen (PSA) 0.03 µg/l). The E170 showed no drift during an 8-hour period and no relevant reagent carryover. Accuracy was confirmed by ring trial experiments and method comparisons vs. Elecsys® 2010. The reliability and practicability of the system’s hardware and software met with, or even exceeded, the evaluator’s requirements. Workflow studies showed that E170 can cover the combined workload of various routine analysers in a variety of laboratory environment. Throughput and sample processing time requirements were achieved while personnel ‘hands-on-time’ could be reduced.
Clinical Chemical Laboratory Medicine, Walter de Gruyter
Print ISSN: 1434-6621
Volume: 42, 10/2004
Pages: 1186 - 1202