Latest development for Osmetech Molecular Diagnostics - bringing molecular diagnostics to near patient testing

Chelsea Technologies Group designed a innovative, rapid and flexible PCR platform for Osmetech Molecular Diagnostics,  making genetic tests a reality in the near point of care market. 

The Opti Gene developed for Osmetech uses proven, well-accepted PCR technology - random access and fully independent thermal cycling in every tube. It permits 12 independent PCR cycles simultaneously; will suited to PCR assay panel testing. It has a rapid thermal cycling time and intuitive touch-screen display and analysis software. Enhanced reliability is gained by having a homogeneous, closed tube format to reduce potential contamination. 

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Current developments for homeland security

On-Site Rapid Diagnostics Screening - Micro-array reader development: infectious disease analysis  

 

Chelsea Technologies Group aids fight for homeland security with launch of On-Site Rapid Diagnostic Screening System
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The Chelsea Technologies Group has developed of an ‘on-site rapid diagnostics screening system’ designed to detect and identify micro-organisms following a terrorist attack.  Over recent years CTG has developed a novel, low-cost, optical system for reading low-density protein microarrays, work that was done in partnership with Microtest Matrices Ltd. (MtM), (a spin out from Imperial College, London). With additional government sponsorship under the Home Office’s CBRN programme, this advance has enabled the CTG, MtM and The Health Inspection Agency (HPA) to develop a fully automated portable microarray processing platform for on-site diagnosis, a step which had hitherto been inhibited by the sophistication and expense of the optical imaging techniques available for reading high density DNA arrays, which until now has been the main driver for the development of this format. The portable platform is designed to be rapidly deployed to any location in the event of a suspected terrorist attack allowing investigators to take samples from the immediate area of the incident – the walls, floor, people etc and screen them quickly to determine whether potentially harmful substances had been used in the attack.  John Attridge, Life Sciences Director, Chelsea Technologies Group, said: “The proposed platform is designed to be rapidly deployed in the event of unexplained clusters of acute illness or fatality, to screen for the presence of a comprehensive panel of micro-organisms that might be associated with a deliberate terrorist attack, allowing these to be ruled out as a potential threat early in any investigation. The microarray format that the team has developed can readily be adapted for other applications, including the detection of potentially harmful chemicals in water supplies or for multianalyte detection in the medical diagnostics market.” A prototype of the platform has been produced and trials are planned for early 2008.

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Quotient Diagnostics Ltd:  rapid point of care test for A1C

Diabetes is a condition already affecting nearly 200 million people. Diabetics can live long and healthy lives if they stay in close control of their condition. Quotient Diagnostics has developed a technology that will revolutionise how it is monitored and managed. Working with Chelsea Technologies Group they have produced an instrument to provide an on-the-spot reading of glycated haemoglobin, a vital indicator of a diabetic's condition, known as the A1C test. Most A1C tests require a larger blood sample to be taken and sent away to a lab for analysis. The quotient solution will make it easy, low cost and quick but just as accurate.  Chelsea worked with Quotient to supply them with five rapid  prototypes.

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At the beginning of 2002 Molecular Sensing approached us with a challenge: to develop a fluorescence based, 24 channel, quantitative PCR system with each channel capable of running an independent thermal profile. A custom moulded sample tube and disposable test cartridge were first designed. An innovative and highly efficiency optical system was devised, which had sub-nanomolar sensitivity in 20mL of sample with a photomultiplier detector operating at relatively low gain, while at the same time being insensitive to component alignment in assembly. A heater circuit was developed to control each of the 24 four channels independently to an accuracy of <0.3^o and stability of +0.05^oC, while also providing the rapid cycling response required by the application. The complete system was developed within a year and the client has now successfully evaluated a number of engineering prototypes.

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The Pulsifier uses a reciprocating beater-bar to send shock waves through a food sample to drive microbes into solution to aid microbial analysis. Food suspensions produced in this way are generally much clearer than can be achieved using traditional blenders and require less downstream processing. Microgen Bioproducts Ltd asked us to production engineer their prototype to meet a competitive price target, reduce operating noise, provide an attractive styling for the product and incorporate microprocessor control. Acoustic analysis indicated that a significant reduction in operating noise could be achieved by sealing the sample within the unit while processing. Further improvements were achieved through a novel crank-arm design that both minimised modes of vibration and enabled the size of the unit to be reduced. The Pulsifier has now transferred into production and has been accepted for use in labs around the world.

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HaemaQuant^TM: the first rapid point of care test for HbA1C

Developed by Chelsea Technologies Group  for Provalis Diagnostics, the HaemaQuant™ demonstrates the success of the close partnership between industrial designers, instrumentation engineers and applications scientists. The Chelsea design team worked closely with Provalis’ biochemists to realise their vision of a portable, low cost assay platform.

HaemaQuant™ has laboratory level photometric performance but with the convenience and clinical advantages of a point-of-care test. It has been designed for low cost manufacture with signal to noise characteristics in the region of 10,000:1 to meet the demanding requirements of the application. We also designed the novel disposable cartridge that provides both the assay platform, for the complex chemical/immunochemical reactions, and provision for photometric analysis of up to 4 liquid fractions.

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Malvern Instruments, the world-leading manufacturer of particle size analysis instrumentation, has recently incorporated a Chelsea designed auto-titrator into their Zetasizer range of products.

This new compact fluid preparation and analysis system was designed to allow precise volumes of up to 3 reagents to be dispensed into a disposable sample container under the control of the Zetasizer system, thus providing an automatic titration facility. Using the auto-titrator, the value of Zetapotential as a function of sample pH is measured enabling precise determination of isoelectric points in fine particle suspensions. This system is available from Chelsea Technologies Group   as an auto-titrator or can be configured for other precise liquid processing applications, where a close link to a specific measurement system is required.

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Drew Scientific asked us to design a compact, low cost, UV fluorimeter that could be incorporated into their DS30 Hcy liquid chromatography system being developed for the routine monitoring of homocysteine, a marker for coronary heart disease. By modifying one of our marine fluorimeters we were able to start experimental investigations immediately. We quickly established the demanding sensitivity requirements and through optimisation of the optical design and detector electronics were able to improve the sensitivity to five times better than the requirement. The time taken from initial client contact to delivery of the first production units was less than 7 months.

A recent redesign replacing the flash source with an LED has enabled a dramatic reduction in production costs to be made with no loss in performance.

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InstaQuant™ was the first development we completed for Provalis Diagnostics. When they approached us they had already developed a visual ‘one-step’ test device for the monitoring of osteoporosis.

The challenge Provalis set us was to develop a simple, lost-cost, hand-held photometer that could provide a more objective quantitative result. Using rapid prototyping techniques a fully functional prototype, virtually identical in appearance to the final product, was produced within 4 months and the final instrument was ready for volume production in less than 10 months. We have investigated & assessed a range of options for analysing strip tests and this 'know how' is available for future developments.

  
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• Design, development and manufacture for Amersham International PLC
• Eccentric bearing drive
• low voltage polymer heaters provide uniform temperature distribution and intrinsic safety
• PID temperature control
• user defined temperature set point and shake/vortex speeds
• over 3500 units produced

• High sensitivity PMT based fluorimeter
• Novel optical design
• Solid state source with telecentric optics
• Precision opto-mechanical interface
• Integrated disposable test device

• Portable lab based clinical analyser
• On board incubation
• Tube/microtitre well based reader
• Integrated assay interpolation
• Design for low cost manufacture

• DNA preparation station
• Production engineering
• Integrated pneumatic / fluidic design
• Pre-production build

• Disposable electrochemical sensing device
• Transfer to manufacture
• Pre-production build

• high speed data acquisition
• data analysis and user interface software
• precision servo control of custom linear motor
• laser fringe subdivision analysis

• low volume precision liquid handling
• pressurized Argon solvent and reagent delivery
• reaction temperature control
• fraction collector for off-line analysis, auto-injector for on-line analysis

• non-radioactive alternative to Carbon 14 energized luminescence standards
• self contained test plate using blue LED light source with optically stabilized output
• stable optical fibre configuration
• high stability with low temperature coefficient
• 500 units in operation