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Translation of the direct-on-blood PCR-NALFIA system into an innovative near point-of-care diagnostic for malaria (DIAGMAL)
Start date: Sep 1, 2013, End date: Aug 31, 2016 PROJECT  FINISHED 

Accurate diagnosis of malaria is essential to timely install proper treatment. Current diagnostic methods for malaria have limitations, such as detection limit and problems with antigen persistence after successful treatment (rapid diagnostic tests) or may require technical expertise and equipment (microscopy). Treatment on the basis of clinical symptoms only (fever = malaria) must be abandoned.Molecular diagnostic tests (MDx) could circumvent some of the mentioned limitations, but tests are incompatable with the Point of Care concept as they require sample processing, have a contamination risk and complicated read-out systems. Although Real-Time PCR assays have overcome some of these problems, the need of large and expensive equipment and the inability to perform it directly on blood shows the need to further improvement and simplification of MDx.Building on the successful outcomes of EU FP7 project “MALACTRES”, the current proposal aims to further built on the concept of a direct on blood PCR system combined with a simple read-out system. This concept has the following advantages:- Direct on blood: no DNA extraction or sample processing;- Simple read-out system (black/white), no need for gel electrophoresis or computer.The proof of concept was delivered in laboratory ring trials and field evaluations in Thailand and Burkina Faso. The proposed diagnostic will have the following additional features:- Direct on blood and simple read-out- Closed system: reduced risk of contamination- Stabilizing reagents included: increased shelf life, no cold storage- Cheap, quick, sensitive and specific.It is envisaged that a full marketable product will be available in 36 months. During development the consortium (dominated by SMEs) will also look into possibilities to adapt the developed system to small hand-held PCR devices preferably in combination with solar-power operated or chargeable batteries that further enhances the application of the test in remote settings.
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