J Lab Med Qual Assur 2015; 37(2): 101-109
Published online June 30, 2015
Copyright © Korean Association of External Quality Assessment Service.
Kiwoong Ko, Min-Jung Kwon, Hee-Yeon Woo, and Hyosoon Park
Department of Laboratory Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
Correspondence to:Min-Jung Kwon
Department of Laboratory Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul 110-746, Korea
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background: The e602, a module of the recently released cobas 8000 modular analyzer series, is an automated system for immunoassays. In this study, we evaluated its analytical performance using 17 immunoassay analytes.
Methods: The Clinical Laboratory Standards Institute guidelines were used to determine the efficiency of the cobas 8000 e602 based on its precision, linearity, assay comparison, and reference range validation. Performance analyses were completed using two levels of quality control materials and pooled sera from our institution. The performance of the cobas 8000 e602 was compared to that of the modular analytics E170. Statistical analyses were performed using Excel 2010 (Microsoft Co., USA) and EP Evaluator Release 10 (Data Innovations, USA).
Results: For all analytes, except level 1 total vitamin D, the coefficients of variation were <5%. The linearity results were within the allowable systemic error limits. The performance comparison revealed that the two systems are comparable, with correlation coefficients (r) >0.975 for all analytes. The reference range validation was also within the allowable criteria.
Conclusions: Taken together, these findings demonstrate that the cobas 8000 e602 analyzer has good precision, linearity, performance comparison, and reference range validation. Thus, e602 is a useful module of the cobas 8000 modular analyzer series.
(J Lab Med Qual Assur 2015;37:101-109)
Keywords: Immunoassay, Performance, Evaluation
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