• Sitemap
  • Contact us

pISSN 2384-2458 eISSN 2288-7261
Article View

Original Article

J Lab Med Qual Assur 2015; 37(2): 101-109

Published online June 30, 2015


Copyright © Korean Association of External Quality Assessment Service.

Evaluation of Analytical Performance of the Cobas 8000 Analyzer Series Module e602

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
Tel: +82-2-2001-5211
Fax: +82-2-757-0711
E-mail: mjkkmd@gmail.com

Received: January 26, 2015; Revised: March 27, 2015; Accepted: April 16, 2015

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


  1. Hendriks HA, Kortlandt W, Verweij WM. Analytical performance comparison of five new generation immunoassay analyzers. Ned Tijdschr Klin Chem 2000;25:170-7.
  2. Wan B, Augustin R, Chan MK, Leblond J, Verjee Z, Adeli K. Analytical performance and workflow evaluation of the Roche E170 modular immunoassay analyzer in a pediatric setting. Clin Biochem 2005;38:262-71.
    Pubmed CrossRef
  3. Hubl W, Zogbaum M, Boyd JC, Savory J, Schubert M, Meyer D, et al. Evaluation of analytical methods and workfl ow performance of the Architect ci8200 integrated serum/plasma analyzer system. Clin Chim Acta 2005;357:43-54.
    Pubmed CrossRef
  4. Lippi G, Dipalo M, Musa R, Avanzini P, Ferrarini C, Pattini A, et al. Evaluation of the analytical performances of the novel Beckman Coulter AU5800. Clin Biochem 2012;45:502-4.
    Pubmed CrossRef
  5. Kim SY, Jeong TD, Lee W, Chun S, Min WK. Performance Evaluation of the Roche-Hitachi cobas 8000 c702 Chemistry Autoanalyzer. Lab Med Online 2014;4:132-9.
  6. McEnroe RJ, Durham AP, Goldford MD, Kondratovich MV, Lababidi S, Magari R, et al. Evaluation of precision of quantitative measurement procedures: approved guideline. 3rd ed. CLSI document EP5-A3. Wayne (PA):Clinical and Laboratory Standards Institute, 2014.
  7. Tholen DW, Kroll M, Astles JR, Caffo AL, Happe TM, Krouwer J, et al. Evaluation of the linearity of quantitative mea surement procedures: a statistical approach: approved guideline. Wayne (PA): Clinical and Laboratory Standards Institute, 2003.
  8. Budd JR, Durham AP, Gwise TE, Iriarte B, Kallner A, Linnet K, et al. Measurement procedure comparison and bias estimation using patient samples: approved guideline. 3rd ed. CLSI document EP09-A3. Wayne (PA):Clinical and Laboratory Standards Institute, 2013.
  9. Clinical and Laboratory Standards Institute. Defining, establishing, and verifying reference intervals in the clinical laboratory: approved guideline. 3rd ed. CLSI document C28-A3. Wayne (PA): Clinical and Laboratory Standards Institute, 2010.
  10. Chen Y, Kinney L, Bozovic A, Smith H, Tarr H, Diamandis EP, et al. Performance evaluation of Siemens ADVIA Centaur and Roche MODULAR Analytics E170 Total 25OH Vitamin D assays. Clin Biochem 2012;45:1485-90.
    Pubmed KoreaMed CrossRef
  11. Wagner D, Hanwell HE, Vieth R. An evaluation of automated methods for measurement of serum 25hydroxyvitamin D. Clin Biochem 2009;42:1549-56.
    Pubmed CrossRef
  12. Krouwer JS, Astles JR, Cooper WG, Gutman SI, Koch DD, Levine JB, et al. Estimation of total analytic error for clinical laboratory methods: approved guideline. CLSI document EP 21-A. Wayne (PA): Clinical and Laboratory Standards Institute, 2003.
  13. Westgard JO, Westgard SA. Total analytic error: from concept to application. Clin Chem News 2013;39:8-10.

Supplementary File

Share this article on :

Stats or metrics