TY - JOUR
T1 - Multicentre performance evaluation of the E170 module for Modular Analytics
AU - Bieglmayer, Christian
AU - Chan, Daniel W.
AU - Sokoll, Lori
AU - Imdahl, Roland
AU - Kobayashi, Masaji
AU - Yamada, Erike
AU - Lilje, Diana J.
AU - Luthe, Hilmar
AU - Meissner, Jochen
AU - Messeri, Gianni
AU - Celli, Alessandra
AU - Tozzi, Paola
AU - Roth, Heinz Jürgen
AU - Schmidt, Frank Peter
AU - Mächler, Marie Luise
AU - Schuff-Werner, Peter
AU - Zingler, Christiana
AU - Smitz, Johan
AU - Schiettecatte, Johan
AU - Vonderschmitt, Dieter J.
AU - Pei, Patrick
AU - Ng, Katherine
AU - Ebert, Christoph
AU - Kirch, Peter
AU - Wanger, Michael
AU - McGovern, Margaret
AU - Stockmann, Wolfgang
AU - Kunst, Albert
PY - 2004
Y1 - 2004
N2 - 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.
AB - 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.
KW - Immunoanalyser
KW - Performance evaluation
KW - Practicability
KW - Workflow
UR - http://www.scopus.com/inward/record.url?scp=8344221937&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=8344221937&partnerID=8YFLogxK
U2 - 10.1515/CCLM.2004.239
DO - 10.1515/CCLM.2004.239
M3 - Article
C2 - 15552279
AN - SCOPUS:8344221937
SN - 1434-6621
VL - 42
SP - 1186
EP - 1202
JO - Clinical Chemistry and Laboratory Medicine
JF - Clinical Chemistry and Laboratory Medicine
IS - 10
ER -