title: Multicentre performance evaluation of the E170 module for modular analytics.
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 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.
authors.affiliation: Klinisches Institut für Medizinische und Chemische Labordiagnostik, AKH Wien, Vienna, Austria.
authors.forename: Christian
authors.initials: C
authors.lastname: Bieglmayer
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Chan
authors.forename: Lori
authors.initials: L
authors.lastname: Sokoll
authors.forename: Roland
authors.initials: R
authors.lastname: Imdahl
authors.forename: Masaji
authors.initials: M
authors.lastname: Kobayashi
authors.forename: Erike
authors.initials: E
authors.lastname: Yamada
authors.forename: Diana J
authors.initials: DJ
authors.lastname: Lilje
authors.forename: Hilmar
authors.initials: H
authors.lastname: Luthe
authors.forename: Jochen
authors.initials: J
authors.lastname: Meissner
authors.forename: Gianni
authors.initials: G
authors.lastname: Messeri
authors.forename: Alessandra
authors.initials: A
authors.lastname: Celli
authors.forename: Paola
authors.initials: P
authors.lastname: Tozzi
authors.forename: Heinz-Jürgen
authors.initials: HJ
authors.lastname: Roth
authors.forename: Frank-Peter
authors.initials: FP
authors.lastname: Schmidt
authors.forename: Marie-Luise
authors.initials: ML
authors.lastname: Mächler
authors.forename: Peter
authors.initials: P
authors.lastname: Schuff-Werner
authors.forename: Christiana
authors.initials: C
authors.lastname: Zingler
authors.forename: Johan
authors.initials: J
authors.lastname: Smitz
authors.forename: Johan
authors.initials: J
authors.lastname: Schiettecatte
authors.forename: Dieter J
authors.initials: DJ
authors.lastname: Vonderschmitt
authors.forename: Patrick
authors.initials: P
authors.lastname: Pei
authors.forename: Katherine
authors.initials: K
authors.lastname: Ng
authors.forename: Christoph
authors.initials: C
authors.lastname: Ebert
authors.forename: Peter
authors.initials: P
authors.lastname: Kirch
authors.forename: Michael
authors.initials: M
authors.lastname: Wanger
authors.forename: Margaret
authors.initials: M
authors.lastname: McGovern
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Stockmann
authors.forename: Albert
authors.initials: A
authors.lastname: Kuns
mesh_terms: D002138:Calibration; D002624:Chemistry, Clinical / Q000379:methods*; D005293:Ferritins / Q000097:blood; D006801:Humans; D008297:Male; D017430:Prostate-Specific Antigen / Q000097:blood; D011933:Reagent Kits, Diagnostic / Q000145:classification / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012984:Software; D013972:Thyrotropin / Q000097:blood; D013995:Time; D014336:Troponin / Q000097:blood
chemical_list: D011933:Reagent Kits, Diagnostic; D014336:Troponin; D013972:Thyrotropin; D005293:Ferritins; D017430:Prostate-Specific Antigen