Analytical performance and workflow evaluation of the Roche E170 modular immunoassay analyzer in a pediatric setting Betty Wan, Roy Augustin, Man Khun Chan, John Leblond, Zulfikarali Verjee, Khosrow Adeli * Division of Clinical Biochemistry, The Hospital for Sick Children, Department of Paediatric Laboratory Medicine, 555 University Avenue, Toronto, Canada M5G 1X8 Received 22 July 2004; received in revised form 25 November 2004; accepted 30 November 2004 Available online 26 January 2005 Abstract Objectives: To evaluate the analytical performance of the Roche E170 modular analytics immunoassay analyzer and assess its impact on workflow efficiency and ability to consolidate workstations in a pediatric setting. Design and methods: Analytical performance of eleven common immunoassays was assessed. Total imprecision was determined using Roche PreciControl Universal controls, Bio-Rad Lyphochek Immuno Plus, Anemia controls, and a human serum pool. Method comparison was performed with approximately 100 patient specimens. High dose hook effect, sample carryover, and results comparison between the two measuring channels were evaluated. For the workflow study, the time required for sample and reagent handling, instrument preparation, and hands-on time were assessed. Results: Correlation coefficients with existing methods ranged from 0.941 to 0.999. Biases of À19% to 70% were observed. Total imprecision ranged from 1.1 to 7.6%. No sample carryovers were encountered. Results from both measuring channels were comparable. Conclusion: E170 is suitable for use in a pediatric setting. The analytical performance is acceptable and gives equivalent results to our existing systems. The precision is comparable and acceptable. Some improvement in efficiency, workflow, cost saving, and consolidation of workstations is possible. Significant workflow improvements can only be realized when integrated with the chemistry modules. D 2004 The Canadian Society of Clinical Chemists. All rights reserved. Keywords: Analytical performance evaluation; Modular immunoassay analyzer; Workflow; Workstations consolidation; Pediatric setting Introduction Process optimization is becoming a major challenge for laboratory managers, especially in the context of consol- idation of disciplines, automation of pre-, peri-, and post- analytical tasks, and shortening turn-around times. The Clinical Biochemistry Laboratory at The Hospital for Sick Children offers a wide range of immunoassay testing and these are offered through a variety of instruments/work- stations. The process of investigating to improve efficiency and minimizing operational costs through better use of technology was recently initiated and is currently on- going. Immunoanalyzers have evolved over the recent years, ranging from stand-alone units to the current integrated modular systems, with linkage to automated sample preparation, robotic sample delivery tracks, and samples archiving/retrieving [1]. New detection technologies com- bined with improved robotics now allow the analysis of analytes across disciplines; Hematology, Biochemistry, and even Microbiology on one measuring platform. The Roche E170 analyzer is an automated, random access, multi- channel, and modular-design system platform for heteroge- neous immunoassays, intended for in vitro quantitative or qualitative determination of a wide range of analytes. The aim of this study was to evaluate the analytical performance 0009-9120/$ - see front matter D 2004 The Canadian Society of Clinical Chemists. All rights reserved. doi:10.1016/j.clinbiochem.2004.11.010 * Corresponding author. Fax: +1 416 813 6257. E-mail address: Khosrow.Adeli@sickkids.ca (K. Adeli). Clinical Biochemistry 38 (2005) 262 – 271