Multicentre performance evaluation of the E170 module for modular analytics.
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.
Bieglmayer
Christian
C
Klinisches Institut für Medizinische und Chemische Labordiagnostik, AKH Wien, Vienna, Austria.
Chan
Daniel W
DW
Sokoll
Lori
L
Imdahl
Roland
R
Kobayashi
Masaji
M
Yamada
Erike
E
Lilje
Diana J
DJ
Luthe
Hilmar
H
Meissner
Jochen
J
Messeri
Gianni
G
Celli
Alessandra
A
Tozzi
Paola
P
Roth
Heinz-Jürgen
HJ
Schmidt
Frank-Peter
FP
Mächler
Marie-Luise
ML
Schuff-Werner
Peter
P
Zingler
Christiana
C
Smitz
Johan
J
Schiettecatte
Johan
J
Vonderschmitt
Dieter J
DJ
Pei
Patrick
P
Ng
Katherine
K
Ebert
Christoph
C
Kirch
Peter
P
Wanger
Michael
M
McGovern
Margaret
M
Stockmann
Wolfgang
W
Kuns
Albert
A
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
D011933:Reagent Kits, Diagnostic; D014336:Troponin; D013972:Thyrotropin; D005293:Ferritins; D017430:Prostate-Specific Antigen