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issue: November 2006 APPLIANCE Magazine European Edition

Controls & Sensors
Chipping Away at Diagnostic Complexity

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by David Simpson, contributing editor

A line of disposable microchips aims to simplify medical diagnostic testing while cutting costs.

The In-Check platform from STMicroelectronics is a molecular diagnostic tool for DNA amplification and analysis. The lab-on-chip brings the exponential power of Polymerase Chain Reaction (PCR) into what the company describes as a cost-effective and convenient format. Finland-based Mobidiag is working with ST on a system to identify specific bacterial species from blood culture samples.

Simplifying the identification of sepsis-causing bacteria is the goal of a new Micro-Electro-Mechanical-System (MEMS) chip-based detector. Developed by STMicroelectronics (Geneva, Switzerland) and Mobidiag (Helsinki, Finland), the lab-on-chip approach is said to provide faster and more reliable results at a fraction of the cost and complexity of conventional laboratory systems. The miniaturized compact solution aims to enable early disease detection, resulting in better treatment choices for patients and lower overall healthcare system costs.
The heart of the system is ST’s In-Check platform. This uses a silicon chip that integrates all the functions needed to identify oligonucleotide sequences in a sample. Chip features include microfluidic handling, a miniaturized PCR (polymerase chain reaction) reactor, and a custom microarray. The chip is mounted on a plastic slide that provides the necessary mechanical, thermal, electrical, and fluidic connections.
ST has also developed an integrated compact high-precision temperature control system (TCS). This permits independent analysis of up to five samples. Another piece of equipment is a portable, customized fluorescent-based optical reader. It analyzes the microarray in a few seconds.
Mobidiag’s contribution to the detector is a pathogen panel to identify 10 sepsis-causing bacterial species, as well as methicillin-resistant strains of Staphylococcus aureus from positive blood culture samples. The diagnostic panel has been designed to optimize the choice of antibiotic therapy in combination with results from Gram staining. This is an empirical comparative method of differentiating bacterial species. Highly accurate and rapid results from the ST/Mobidiag solution are designed to reduce the risks of antibiotic misuse. Results help physicians select the right treatment as early as possible.

High-Tech Diagnosis

The lab-on-chip platform amplifies clinically relevant DNA samples by PCR. Common sample sizes range from just 2 microliters to 8 microliters. The microfluidic design reduces the PCR cycle time by about 70 percent compared to the same protocol run on a conventional thermocycler. Microreactors buried in the MEMS chip carry the mixture of sample and reagents. The surfaces in contact with the fluid are biocompatible and do not inhibit polymerase. On-chip heating elements perform the temperature cycling in conjunction with the TCS.
The risks of cross-contamination inherent in conventional analysis methods are minimized as well. The PCR processor can be loaded directly and sealed to prevent evaporation during temperature cycles. The PCR and analysis are performed on-chip in an encapsulated, self-contained unit.
The TCS actuates, monitors and adjusts the reaction parameters. The device comprises five control modules with independent thermal protocols and random access capability. Thanks to the temperature control of the PCR solution, the In-Check platform ensures a high specificity of the amplified products, compared to a conventional thermocycler.
Optical signal acquisition is performed by a dedicated portable reader and processed by ST’s specialized bioinformatics software. This can be installed on any PC. The software operates with Mobidiag’s clinical reporting processes, and analyzes the results. It also generates reports compliant with MIAME (Minimum Information About a Microarray Experiment) standards. This permits unambiguous interpretation of data from DNA tests.
“Early detection of systemic bacterial infections is essential for the successful management of antibiotic therapy,” observes Jaakko Pellosniemi, CEO of Mobidiag. “The In-Check platform is ideally suited to exploit the advantages of the unique diagnostic microbiological panels. Our product will markedly improve the quality of treatment choices, leading to better patient outcomes and reduced healthcare costs.”
According to Stefano LoPriore of ST’s lab-on-chip team, the advantages lie in the possibility of having a faster answer on the diagnosis of pathogens. “Having the laboratory operations performed by a less highly trained operator enables point-of-care applications, and at reduced costs,” he says. “We see it first used in clinical laboratories, shortening the chain between patient and testing lab, and thus diagnosis. Later we see it going into field testing situations, also known as point-of-care—doctors’ offices, airports, developing countries….”
Currently, the two companies are developing the applications that will run on In-Check. They plan to shortly be in clinical trials for the first applications. ST is also working with another company, Veredus Laboratories Pte Ltd. based in Singapore, on an In-Check application. This would be a fast, point-of-need diagnostic tool that would enable health practitioners to quickly detect strains of Avian Flu and other influenza viruses.

Suppliers mentioned in this article:
Micro Electro Mecanica

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