Jump to ContentJump to Main Navigation
Show Summary Details
More options …

Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

Online
ISSN
1437-4331
See all formats and pricing
More options …
Volume 42, Issue 10

Issues

Multicentre performance evaluation of the E170 Module for MODULAR ANALYTICS

Christian Bieglmayer
  • Klinisches Institut für Medizinische und Chemische Labordiagnostik, AKH Wien, Vienna, Austria
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ 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. Vonderschmitt / Patrick Pei / Katherine Ng / Christoph Ebert / Peter Kirch / Michael Wanger / Margaret McGovern / Wolfgang Stockmann / Albert Kunst
Published Online: 2011-09-21 | DOI: https://doi.org/10.1515/CCLM.2004.239

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.

Keywords: immunoanalyser; performance evaluation; practicability; workflow

References

  • 1

    Stockmann W, McGovern M, Ng K. The analytical performance of the Roche/Hitachi MODULAR ANALYTICS [abstract]. Clin Chem Lab Med 1999; 37;Suppl:S400.Google Scholar

  • 2

    Stockmann W, Engeldinger W, Kunst A, McGovern M, Ng K. Assessment of the Roche/Hitachi MODULAR ANALYTICS under simulated routine conditions in 16 European and US laboratories [abstract]. Clin Chem Lab Med 1999; 37;Suppl:S400.Google Scholar

  • 3

    Neumeier D, Chan DW. Multicentre evaluation of the Boehringer Mannheim Elecsy® 2010 immunoassay system. Wien Klin Wochenschr 1998; 110:Suppl 3:5–68.Google Scholar

  • 4

    Myers MB. Elecsys® immunoassay systems. In: Wild D, editor. The immunoassay handbook. London: Macmillan Reference Ltd., 2000:341–6.Google Scholar

  • 5

    Guidelines for the evaluation of analysers in clinical chemistry. ECCLS document, 1986;3:no. 2.Google Scholar

  • 6

    NCCLS evaluation protocols, ISBN-1-56238-146-6, Order Code SC 1, National Committee for Clinical Laboratory Standards. Villanova, PA, 1992.Google Scholar

  • 7

    Bablok W, Stockmann W. An alternative approach to a system evaluation in the field [abstract]. Quim Clin 1995; 14:239.Google Scholar

  • 8

    Bablok W, Barembruch R, Stockmann W, Brauer P, Graber P, Michel R, et al. CAEv – a program for computer aided evaluation. J Autom Chem 1991; 13:167–79.CrossrefGoogle Scholar

  • 9

    Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. J Clin Chem Clin Biochem 1983; 21:709–20.Google Scholar

  • 10

    Stockmann W, Bablok W, Poppe W, Bayer PM, Keller F, Schweiger CR. Criteria of practicability. In: Haeckel H, editor. Evaluation methods in laboratory medicine. Weinheim: VCH, 1993:185–201.Google Scholar

  • 11

    Ricos C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, et al. Current databases on biological variation: pros, cons and progress. Scand J Clin Lab Invest 1999; 59:491–500.CrossrefGoogle Scholar

  • 12

    Apple FS, Wu AHB. Myocardial infarction redefined: role of cardiac troponin testing. Clin Chem 2001; 47:377–9.Google Scholar

About the article

Received: 2004-03-19

Accepted: 2004-08-20

Published Online: 2011-09-21

Published in Print: 2004-10-01


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 42, Issue 10, Pages 1186–1202, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2004.239.

Export Citation

© Walter de Gruyter.Get Permission

Citing Articles

Here you can find all Crossref-listed publications in which this article is cited. If you would like to receive automatic email messages as soon as this article is cited in other publications, simply activate the “Citation Alert” on the top of this page.

[1]
Tanja Dekkers, Jaap Deinum, Leo J. Schultzekool, Dirk Blondin, Oliver Vonend, Ad R.R.M. Hermus, Mirko Peitzsch, Lars C. Rump, Gerald Antoch, Fred C.G.J. Sweep, Stefan R. Bornstein, Jacques W.M. Lenders, Holger S. Willenberg, and Graeme Eisenhofer
Hypertension, 2013, Volume 62, Number 6, Page 1152
[2]
P. Findeisen, I. Zahn, G.M. Fiedler, A.B. Leichtle, S. Wang, G. Soria, P. Johnson, J. Henzell, J.K. Hegel, C. Bendavid, N. Collet, M. McGovern, and K. Klopprogge
Clinical Biochemistry, 2018
[3]
M Liem-Moolenaar, E T te Beek, M L de Kam, K L Franson, R S Kahn, R Hijman, D Touw, and J MA van Gerven
Journal of Psychopharmacology, 2010, Volume 24, Number 11, Page 1697
[4]
David J Handelsman, Ken Sikaris, and Lam P Ly
Annals of Clinical Biochemistry, 2016, Volume 53, Number 3, Page 377
[5]
Arnold von Eckardstein, Hans Jürgen Roth, Graham Jones, Sharon Preston, Thomas Szekeres, Roland Imdahl, Marc Conti, Norbert Blanckaert, Darren Jose, Joachim Thiery, Lisa Feldmann, Nicolas von Ahsen, Massimo Locatelli, Jenni Kremastinou, Albert Kunst, Arnulf Hubbuch, and Margaret McGovern
Journal of Laboratory Automation, 2013, Volume 18, Number 4, Page 306
[6]
Michael Vogeser, Maria Shipkova, Raül Rigo-Bonnin, Pierre Wallemacq, Matthias Orth, Monika Widmann, and Alain G. Verstraete
Therapeutic Drug Monitoring, 2014, Volume 36, Number 5, Page 640
[7]
G. M. Hirschfield, J. R. Gallimore, M. C. Kahan, W. L. Hutchinson, C. A. Sabin, G. M. Benson, A. P. Dhillon, G. A. Tennent, and M. B. Pepys
Proceedings of the National Academy of Sciences, 2005, Volume 102, Number 23, Page 8309
[8]
Wolfgang Stockmann, Werner Engeldinger, Albert Kunst, and Margaret McGovern
Journal of Automated Methods and Management in Chemistry, 2008, Volume 2008, Page 1
[9]
Paolo Mocarelli, Gary L. Horowitz, Pier Mario Gerthoux, Rossana Cecere, Roland Imdahl, Janneke Ruinemans-Koerts, Hilmar Luthe, Silvia Pesudo Calatayud, Marie Luisa Salve, Albert Kunst, Margaret McGovern, Katherine Ng, and Wolfgang Stockmann
Journal of Automated Methods and Management in Chemistry, 2008, Volume 2008, Page 1
[10]
A. Veronica Witte, Markus Savli, Alexander Holik, Siegfried Kasper, and Rupert Lanzenberger
NeuroImage, 2010, Volume 49, Number 2, Page 1205
[11]
Rupert Lanzenberger, Markus Mitterhauser, Georg S. Kranz, Christoph Spindelegger, Wolfgang Wadsak, Patrycja Stein, Ulrike Moser, Markus Savli, Kurt Kletter, and Siegfried Kasper
Neuroendocrinology, 2011, Volume 94, Number 1, Page 84
[12]
Péter Antal-Szalmás, Gergely Ivády, Attila Molnár, Zsuzsa Hevessy, Valéria Kissné Sziráki, Anna V. Oláh, Ágota Lenkey, and János Kappelmayer
Orvosi Hetilap, 2007, Volume 148, Number 28, Page 1317

Comments (0)

Please log in or register to comment.
Log in