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Responding to market needs

Emerging trends in clinical labs have influenced developments in IVD automation and instrumentation.

During the past few years, a number of trends in laboratory medicine have affected the development and implementation of automation in lab analyzers. Such trends are related to reducing costs, running tests with fewer lab personnel, and maintaining quick turnaround times for test results. This special supplement on automation and instrumentation for IVDs explores such trends and how manufacturers have responded to them.

One trend is automating the preanalytical sample preparation steps, including registering samples in the laboratory information system, centrifuging blood tubes, and preparing them to be sampled. Seeing this trend, several major IVD manufacturers have developed and offer automated sample prep systems.

In this supplement, authors Ron Berman, Paul Ashton, and Jeff Quint of Beckman Coulter Inc. (Brea, CA) discuss developments in preanalytical process automation technologies. Their article, “Automating Sample Processing to Improve Clinical Laboratory Workflow” (click here), examines how such technologies can improve lab workflow while minimizing testing errors attributable to sample handling.

As the post-genomic era continues to unfold, another trend is the increasing number of samples arriving in laboratories for molecular analysis. Such increases place added demands on automated instruments that can handle the specialized needs of molecular tests. For example, lab automation will need to be able to conduct closed-tube sampling for DNA analysis in order to minimize the increased risk of cross-contamination.

Authors Brad Tieman, Jerzy Macioszek, Craig Hill, and Matthew Friedenberg of Gen-Probe Inc. (San Diego) discuss developments in fully automated nucleic acid amplification testing. Their article, “Developing a Fully Automated Instrument for Molecular Diagnostics Assays” (click here), examines how such IVDs can improve not only infectious disease testing and blood screening, but also many other areas of clinical testing in genetics and cancer.

In addition, with so much of a lab’s work load concentrated on a few analyzers, any downtime due to instrument malfunctions is disastrous. In the past few years, remote instrument analysis via device relationship management (DRM) has become an integral part of instrument quality control. DRM is software that enables interactive monitoring and servicing of lab instruments through the Internet. It also allows IVD manufacturers to run routine instrument maintenance and inspection activities from a remote location.

Author Richard Jefferson of BD Diagnostics (Franklin Lakes, NJ) discusses the development of a software platform for a microbiology data management system. His article, “Using Software to Improve the Development Efficiency of Diagnostic Systems” (click here), examines how this system was designed to address not only the needs of customers, but also the rapidly changing nature of microbiology and the complex problem of inefficiency in new system development.

Richard Park

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