Multicentre performance evaluation of the E170 module for Modular Analytics

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, Peter Schuff-Werner, Christiana Zingler, Johan Smitz, Johan Schiettecatte, Dieter J. VonderschmittPatrick Pei, Katherine Ng, Christoph Ebert, Peter Kirch, Michael Wanger, Margaret McGovern, Wolfgang Stockmann, Albert Kunst

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1186-1202
Number of pages17
JournalClinical Chemistry and Laboratory Medicine
Volume42
Issue number10
DOIs
StatePublished - 2004

Keywords

  • Immunoanalyser
  • Performance evaluation
  • Practicability
  • Workflow

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

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