This chapter explains the technology and chemistry behind the VITROS^® ECiQ Immunodiagnostic System, VITROS^® 3600 Immunodiagnostic System, and VITROS^® 5600 Integrated System. These random-access analyzers provide quantitative determination of a broad range of analytes. The system includes analyzers, reagent packs and generic reagents. Samples may be loaded at any time and urgent requests can be run in Stat mode. The immunoassays are based on enhanced luminescence, using horseradish peroxidase enzyme as the label and luminol as the substrate, with peracid salt and an enhancer to create a glow of light as the signal. Assay designs may be competitive or immunometric. The features of the system are listed, and the design and principles explained. There are also sections on calibration, antibodies, separation, signal generation and detection, and data processing, including interfacing to laboratory information systems.

Ortho Clinical Diagnostics has been divested from the Johnson & Johnson family of companies and is now a privately owned company.

David Wild wrote the original chapter, which was revised by John Backus, previously Director, Scientific Affairs, Ortho Clinical Diagnostics.

Maria-Magdalena Patru (mpatru11@its.jnj.com) is now the contact for readers making enquiries about the Vitros® ECiQ Immunodiagnostic System, Vitros® 3600 Immunodiagnostic System and Vitros® 5600 Integrated System product ranges.

David Wild’s career spans 40 years in diagnostics, medical devices, pharmaceuticals and biotechnology. As a University of London undergraduate, he won the Driver Prize for Biochemistry after discovering an extra electron transfer step in photosynthesis. As leaders of the University Biochemistry Society, he and his girlfriend Cindy (now wife) hosted lectures by Sir Hans Krebs and Roger Ekins. After graduation, he worked first as a molecular biologist at a pharmaceutical company R&D laboratory, then, for 25 years, in immunodiagnostics, managing product development and industrial engineering projects. More recently he managed large medical device R&D and operational projects. He worked for Amersham, Kodak, Johnson and Johnson, Bristol-Myers Squibb and ConvaTec. His Director level positions include Research and Development, Design Engineering, Global Manufacturing, and Strategy. He indulges his passion for immunoassays as Managing Editor of The Immunoassay Handbook and lectures, trains and consults on development, manufacturing and marketing strategies, and how to integrate and execute them.

Maria-Magdalena Patru, MD, PhD, is Manager, Medical and Scientific Affairs at Ortho Clinical Diagnostics.   During her professional life, Maria has held scientific and clinical fellowship positions and has more than 6 years of experience in the field of medical devices, including immunodiagnostics, clinical chemistry, microbiology, novel biomarkers, and molecular diagnostics.  Maria earned her medical degree in Romania, from the internationally recognized University of Cluj-Napoca School of Medicine and Pharmacy, and her PhD in Microbiology and Immunology from University of Rochester, NY.  Her thesis research focused on identifying enzymes involved in mycobacterial peptidoglycan biosynthesis with role in survival under non-replicating conditions.

VITROS^®, ECiQ, microwell, horseradish peroxidase, luminol, chemiluminescence, random access, competitive, immunometric, calibration, antibodies, separation, signal generation, signal detection, Stat test.