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A new system for the rapid isolation and safe incubation of tuberculosis

Objective



The World Health Organisation has declared tuberculosis a Global Emergency, and has forecast that over 30,00,000 people will die of the disease in the next decade. TB is highly infectious and it is estimated that over 25% of new cases arise as a result of incorrect diagnosis. With fast, accurate diagnosis and correct and timely drug therapy, the disease can be treated, and lives can be saved. Current diagnostic methods are expensive, slow or grossly inaccurate. The WHO has set the year 2000 as the target date for the diagnostic industry to develop and introduce a new diagnostic test that is accurate, rapid, low cost, robust, and simple and safe to use. No currently available method fully meets these criteria. Such a test would be particularly suited to the needs of the low-income countries of the world where the problem of TB is generally most acute. Our project seeks to develop a safe, rapid method of accurate TB diagnosis, that would have wide application in the developed and developing countries throughout the world, and will meet the challenging target set by the WHO. Safety is achieved by enclosing the specially configured diagnostic test in a self-contained category 3 workstation. Our proposed methodology is highly innovative and is based on the development of a novel assay that makes use of bacterio-phage with a specific affinity to Mycol bacterium tuberculosis, a selective virucide, and specially selected "helper bacteria", to detect very rapidly the presence of low numbers of the target bacteria in patient samples. This assay will allow a complete analysis of a day's throughput of prepared samples to be fully contained within a unique workstation and provide maximum operator protection against infection from the samples during the assay process. The integrated design of the assay and workstation forms the basis of our project. The assay can be adapted to provide rapid drug susceptibility testing, such that the patient may accurately be prescribed the most appropriate drug reghne. The accurate use of drugs minimises the spread of drug resistant strains of the disease. Our system will allow complete sample analysis within a 24 hours cycle rather than within the four weeks or more required of culture based confirmatory tests most commonly used in the developing countries. The system is capable of automation to meet the specialist requirements of the developed world. Our system is generic and can, with further development, be applied to the detection of other bacteria and be applied in other non clinical markets.

The process is capable of miniaturisation Four SMEs will collaborate on the project. One has secured exclusive rights to the underlying patents, and is experienced in the development, manufacture and marketing of diagnostic products world wide. This will be the project leader. Two of the others are experts in the manufacture and marketing of self contained incubation systems and controlled environment systems, and will be responsible for the development of the workstation. One is a distributor of diagnostic kits and hardware, and will undertake trials and provide feedback from the field. The RTD providers are centres of excellence in relevant aspects of the development of the assay, of the design of semi automation handling systems, and in the development of assays and the diagnostic testing of infectious diseases especially TB. We are involving hospital testing laboratories in the UK, in Portugal, and in South Africa and Zambia where the high number of TB cases is a major problem. The SME's believe that the project offers a very significant commercial opportunity and the prospect of considerable company growth. In addition success will make a major contribution towards improving world health.

Call for proposal

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Coordinator

Biotec Laboratories Ltd.
EU contribution
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Address
Anson Road
IP5 3RG Martelsham - Ipswich
United Kingdom

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Total cost
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Participants (8)