Journal of Automated Methods and Management in Chemistry 
Volume 2005 (2005), Issue 1, Pages 8-25
doi:10.1155/JAMMC.2005.8

MODULAR ANALYTICS: A New Approach to Automation in the Clinical Laboratory

Gary L. Horowitz,1 Zahur Zaman,2 Norbert J. C. Blanckaert,2 Daniel W. Chan,3 Jeffrey A. Dubois,4 Olivier Golaz,5 Noury Mensi,5 Franz Keller,6 Herbert Stolz,6 Karl Klingler,7 Alessandro Marocchi,8 Lorenzo Prencipe,8 Ronald W. McLawhon,9 Olaug L. Nilsen,10 Michael Oellerich,11 Hilmar Luthe,11 Jean-Luc Orsonneau,12 Gérard Richeux,12 Fernando Recio,13 Esther Roldan,13 Lars Rymo,14 Anne-Charlotte Wicktorsson,14 Shirley L. Welch,15 Heinrich Wieland,16 Andrea Busse Grawitz,16 Hiroshi Mitsumaki,17 Margaret McGovern,18 Katherine Ng,19 and Wolfgang Stockmann19

1Department of Pathology, Beth Israel DeaconessMedical Center, Boston 02215-5400, MA, USA
2Department of Laboratory Medicine, University Hospitals Leuven, Leuven 3000, Belgium
3Department of Pathology, Johns Hopkins Medical Institutions, Baltimore 21287-0001, MD, USA
4Laboratory Services Foundation, University Hospitals of Cleveland, Cleveland 44106, OH, USA
5Laboratoire Central de Chimie Clinique, Hôpitaux Universitaire de Genève, Geneva 1211, Switzerland
6Zentrallabor, Institut für Klinische Biochemie und Pathobiochemie, Universitaetsklinik Wuerzburg, Wuerzburg 97080 , Germany
7Institut für Klinische Chemie der Universität zu Köln, Köln 50924, Germany
8Department of Laboratory Medicine, Niguarda Ca' Granda Hospital, Milan 20162 , Italy
9Department of Pathology, The University of Chicago Hospitals and Health System, Chicago 60637-1470, IL, USA
10Fuerst Medical Laboratory, Oslo 1051, Norway
11Department of Clinical Chemistry, Georg-August-Universitaet, Goettingen 37075, Germany
12Laboratoire de Biochimie Générale, Centre Hospitalier Universitaire de Nantes, Nantes Cédex 01 44035, France
13Laboratorio de Bioquímica, Hospital Universitario de Valme, Sevilla 41014, Spain
14Department of Clinical Chemistry and Transfusion Medicine, Institute of Laboratory Medicine, Sahlgrenska University Hospital, Gothenborg 41345 , Sweden
15Kaiser Permanente NW Department of Pathology, Regional Laboratory, Portland 97230, OR , USA
16Klinikum der Albert-Ludwigs-Universitaet, Medizinische Klinik, Abt. Klinische Chemie, Zentrallabor, Freiburg 79106, Germany
17Hitachi Ltd, Tokyo 100-8220, Japan
18Roche Diagnostics GmbH, Mannheim 68305, Germany
19Roche Diagnostics, Indianapolis 46250, IN , USA

Received 30 June 2004; Accepted 18 August 2004

Abstract

MODULAR ANALYTICS (Roche Diagnostics) (MODULAR ANALYTICS, Elecsys and Cobas Integra are trademarks of a member of the Roche Group) represents a new approach to automation for the clinical chemistry laboratory. It consists of a control unit, a core unit with a bidirectional multitrack rack transportation system, and three distinct kinds of analytical modules: an ISE module, a P800 module (44 photometric tests, throughput of up to 800 tests/h), and a D2400 module (16 photometric tests, throughput up to 2400 tests/h). MODULAR ANALYTICS allows customised configurations for various laboratory workloads. The performance and practicability of MODULAR ANALYTICS were evaluated in an international multicentre study at 16 sites. Studies included precision, accuracy, analytical range, carry-over, and workflow assessment. More than 700 000 results were obtained during the course of the study. Median between-day CVs were typically less than 3% for clinical chemistries and less than 6% for homogeneous immunoassays. Median recoveries for nearly all standardised reference materials were within 5% of assigned values. Method comparisons versus current existing routine instrumentation were clinically acceptable in all cases. During the workflow studies, the work from three to four single workstations was transferred to MODULAR ANALYTICS, which offered over 100 possible methods, with reduction in sample splitting, handling errors, and turnaround time. Typical sample processing time on MODULAR ANALYTICS was less than 30 minutes, an improvement from the current laboratory systems. By combining multiple analytic units in flexible ways, MODULAR ANALYTICS met diverse laboratory needs and offered improvement in workflow over current laboratory situations. It increased overall efficiency while maintaining (or improving) quality.