Rapid Molecular Detection of Tuberculosis without PCR amplification

Project Summary TuberculosisTBis a major global burden that killsmillion people every yearTB mostly affects developing countriesbut the rise of multi drug and extensively drug resistant strains is a global threatIn order to control and eradicate this diseaseit is imperative to have adequate tools to detect active TB in limited resource settings and point of carePOCsettingswhich is where most TB patients are seenHoweveravailable detection methods have poor performance and are not suited for diagnosis in limited resource or POC settingsThe most commonly used method to detect TB is smear microscopya procedure developed more thanyears ago that only detectsof the casesIn Phase Iwe developed a sample preparation and detection procedure that is rapidrobusteasy to automateand highly sensitive and specificThe new assay is based on Single Molecule ScanningSMSa novel technology capable of detecting single molecules using simple equipmentHerewe will develop a fully automated next generation molecular test based on the feasibility of SMS stablished in Phase IThe goal is to replace smear microscopy for sputumbased diagnosis of TB in high TB burden countries and to replace PCR based TB diagnosis in developed countriesIf successfulthe new assay will be more accurate than the current leader molecular assayandgtsensitivityandgtspecificityand its price will be affordable for limitedresource settings$test$instrumentIn additionthe new assay will satisfy all the characteristics that according to a WHO report are required in a product to replace smear microscopyThe overall goal of Phase IIis to develop and to validate a disposable cartridge and a fully automated instrument for TB testingAimfocuses on the development of the disposable cartridgeAimon the development of the portable instrument and Aimon the verification and clinical validation of the final instrument and cartridge designThis evaluation together with the design documentation accumulated during the project will be combined with additional clinical evaluations to obtain CE markFDA approvalapproval in high TB burden countriesand the endorsement of the World Health Organization Narrative We propose the development of a novel technology for rapid detection of active tuberculosis without enzymatic reactionsWe will develop and validate a disposable cartridge and a fully automated instrument