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Multicentre performance evaluation of the E170 Module for MODULAR ANALYTICS

2004; De Gruyter; Volume: 42; Issue: 10 Linguagem: Inglês

10.1515/cclm.2004.239

1437-4331

Christian Bieglmayer, Daniel W. Chan, Lori J. Sokoll, Roland Imdahl, Masaji Kobayashi, Erike Yamada, Diana J. Lilje, Hilmar Luthe, Jochen Meissner, Gianni Messeri, Alessandra Celli, Paola Tozzi, H. J. Roth, Frank-Peter Schmidt, Marie-Luise Mächler, P. Schuff‐Werner, Christiana Zingler, Johan Smitz, Johan Schiettecatte, Dieter J. Vonderschmitt, P. Pei, Katherine Ng, Christoph Ebert, Peter Kirch, Michael Wanger, Margaret M. McGovern, Wolfgang Stockmann, Albert Kunst,

Biosimilars and Bioanalytical Methods

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