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P. vivax is considered the most difficult human malaria to eliminate because of the inability of conventional diagnostics to detect individuals with latent liver forms. These individuals account for 80% of all infections and can readily infect mosquitoes. Currently countries can test knowing this has little impact or and the treat everyone which exposes individuals to drugs with potentially dangerous side effects. Parasite specific antibody responses have been shown to correlate with the likelihood of hypnozoite carriage and can be used to identify individuals who should be treated. Aim is to implement a Cluster-Randomised Trial in Ethiopia and Madagascar to demonstrate the effectiveness of a new anti-malaria intervention based on Plasmodium vivax serological testing and treatment (PvSTATEM) with primaquine to prevent the relapse infections responsible for maintaining P. vivax transmission. Simultaneously, we will assess social and health system acceptability of such an approach as well as refine new mobile technologies which interface with point-of-care diagnostic tests and guide treatment decisions. We aim to reduce malaria burden at both the individual and population level in two countries which experience the highest levels of P.vivax in Africa. We expect to have a significant effect in reducing morbidity and improving health. We will ensure community engagement and assess the adoption of new technologies that align with those existing in the health system. The proposal is built on equal partnership and shared capacity to address a substantial public health burden.
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We are proposing to develop a molecular assay for the safe, rapid, specific and sensitive detection of Ebola Virus Infection in capillary (or venous) blood samples combining ALTONA’s Pan-filo screening IVD test with the existing Alere™ q point of care molecular diagnostics platform. The purpose of this project is to utilize existing and proven PCR assay(s) designed for laboratory use and to take advantage of the Alere™ q point of care molecular instrument and cartridge design to simplify Ebola testing so that molecular testing can be expanded to sites beyond which high end laboratory infrastructure is not available while simultaneously greatly reducing infection risk for the test operator. The project aims for the fast development of a point of care Nucleic Acid Test (POC-NAT) system for filovirus specific RNA, from human sample material, especially from blood samples. The POC-NAT system will have the following features: 1. Field proven stand alone, mobile and easy to use instrumentation 2. ready to use cartridge, safely disposable nucleic acid test format with integrated sample preparation 3. assay for specific detection of RNA of all known species from the virus genera Ebola- and Marburgvirus . 4. process duration from sampling to result less than 45 min 5. no additional equipment and no logistics and storage at -20°C needed The POC-NAT is based on two already existing technologies: The instrument platform “Alere™q complete” developed and manufactured by Alere , an instrument for POC diagnostics recently used p.e. for Alere´s HIV-1/2 Detect cartridges, and altona Diagnostics´ RealStar® Filovirus RT-PCR kit 1.0, a commercial central laboratory real-time PCR test. The project partner aim for having the integration of platform and assay as a prototypic system completed until end of March 2015. The verification and validation of the workflow starts April 2015 at altona Diagnostics, BNITM and INMI. The aim of this project phase is to finally CE IVD mark the test system
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The A-Patch Research & Innovation project will research, innovate, push technology barriers, and demonstrate innovative use of Flexible and Wearable Electronics in the medical and well-being sectors, validate its prototype devices in lab and hospital environments (TRL 4-5). Industrial exploitation of the A-Patch applications will be clearly identified. The project will develop non-invasive autonomous wearable diagnostic patches for real-time remote monitoring of infection status. The A-Patch will use a novel intelligent hybrid sensor array with multiplexed detection capabilities to detect disease-specific volatile organic compounds (VOCs) from the surface of the skin, enabling rapid and highly-accurate diagnosis using a small device. Product innovations for professionals and consumers will be incorporated, and benefits demonstrated. Integration of electronic devices in connected wearable, flexible and stretchable settings, low-power interconnection, compatibility with low-cost manufacturing, efficient energy scavenging and storage, functional performance, and durability will be successfully demonstrated. To ensure reliability and enable extended usage periods, the sensor array will be self-repairing and the device will be self-powered, by advancing cutting-edge research on chemical hybrid sensors and materials. A-Patch will incorporate secure transmission to enable privacy-ensured diagnosis monitoring by physicians, national health systems and worldwide health organisations. The project partners include a health-maintenance organisation, a diagnostic test implementer with in-depth understanding of end-user needs, technology developers, academic / research institutes and a system integrator. The project is planned for a 36-month duration and is estimated to require total funding of 4 M€.
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