Multicentre performance evaluation of the E170 module for modular analytics

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) fo...

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Bibliographic Details
Published in:	Clinical chemistry and laboratory medicine Vol. 42; no. 10; p. 1186
Main Authors:	Bieglmayer, Christian, Chan, Daniel W, Sokoll, Lori, Imdahl, Roland, Kobayashi, Masaji, Yamada, Erike, Lilje, Diana J, Luthe, Hilmar, Meissner, Jochen, Messeri, Gianni, Celli, Alessandra, Tozzi, Paola, Roth, Heinz-Jürgen, Schmidt, Frank-Peter, Mächler, Marie-Luise, Schuff-Werner, Peter, Zingler, Christiana, Smitz, Johan, Schiettecatte, Johan, Vonderschmitt, Dieter J, Pei, Patrick, Ng, Katherine, Ebert, Christoph, Kirch, Peter, Wanger, Michael, McGovern, Margaret, Stockmann, Wolfgang, Kuns, Albert
Format:	Journal Article
Language:	English
Published:	Germany 01-01-2004
Subjects:	Calibration Chemistry, Clinical - methods Ferritins - blood Humans Male Prostate-Specific Antigen - blood Reagent Kits, Diagnostic - classification Reagent Kits, Diagnostic - standards Reproducibility of Results Sensitivity and Specificity Software Thyrotropin - blood Time Troponin - blood
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Summary:	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 microg/l, total prostate-specific antigen (PSA) 0.03 microg/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.
ISSN:	1434-6621
DOI:	10.1515/CCLM.2004.239