{"id":56666,"key":"Global_Health_Medical_Device_Compendium/TBDx","title":"Global Health Medical Device Compendium/TBDx","latest":{"id":1267789,"timestamp":"2026-09-10T14:29:45Z"},"content_model":"wikitext","license":{"url":"https://www.appropedia.org/Appropedia:Copyrights","title":"CC-BY-SA-4.0"},"source":"[[File:Tbdx.jpg|thumb]]\n\n{{GHMDC device data\n| health-topic = Tuberculosis,\n| classification = Diagnosis\n| scope = Clinical trial\n| manufacturer-location = Virginia, United States\n}}\n\nWith drug-resistant strains of TB outpacing the effectiveness of available treatments, this disease is again on the rise, infecting more than 8 million people every year. As the current treatments are expensive (up to 40000$), TB is prevalent in resource-limited settings. To prevent the spreading of this disease, accurate, efficient, and quick diagnosis is required.\n\n== Detailed description of the solution ==\n\nTBDx is a fully automated sputum smear (mucus) microscopy diagnostic solution for the detection of TB. It adds image processing to the routine smear microscopy, has a step-by-step guide for setup and process initialization, utilizes touchscreen capabilities and simple to understand features, and can support up to a 200-slide autoloader system for higher production environments. These features, combined with a lower cost-per-slide (~2.50$ compared to 10$), a reduction in the manpower needed (fully automated system), its ability to be used in a mobile laboratory environment, and its speed (reduced time from 6 minutes per slide to 2) can lead to savings of 79$ per case detected, or 66.9% savings of the typical cost of diagnosis. (http://appliedvs.files.wordpress.com/2013/08/tbdx_gxp-cost-analysis.pdf).\n\n== Designed by ==\n\n* Designed by: Signature Mapping Medical Sciences, Inc.\n* Manufacturer (if different): Guardian\n* Manufacturer location: Virginia, USA\n\n== When and where it was tested/implemented ==\n\nThe TBDx held clinical trials in South Africa, and the Aurum Institute for Health Research ordered three TBDx systems in 2011.\n\n== Funding Source ==\n\nUS President's Emergency Plan for AIDS Relief (PEPFAR)\n\n== References ==\n\n=== Peer-reviewed publication ===\n\n* Lewis J, Chihota V, van der Meulen M, Fourie P, Fielding K, Grant A, Dorman S, Churchyard G. \"Proof-Of-Concept\" Evaluation of an Automated Sputum Smear Microscopy System for Tuberculosis Diagnosis (Nov 29 2012). Retrieved July 1, 2014 from\n\nhttp://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0050173\n\n=== Other internally generated reports ===\n\n* Signature Mapping TBDxTM Technical Data Sheet. Retrieved 1 July, 2014 from\n\nhttp://tbevidence.org/documents/rescentre/sop/SMTBDX%20System%20Datasheet%20V11%20Automated.pdf\n\n=== Externally generated reports ===\n\n* Applied Visual Sciences. \"TBDx and GeneXpert (GXP): Laboratory Algorithm for Case Findings and Cost Savings\" (Aug 2013). Retrieved on Aug 18, 2014 from http://appliedvs.files.wordpress.com/2013/08/tbdx_gxp-cost-analysis.pdf.\n* Conway-Smith E. (Mar 24 2014). \"Why Africa's drug-resistant tuberculosis is proving so hard to fight.\" Retrieved July 2, 2014 from http://www.globalpost.com/dispatch/news/regions/africa/140321/tuberculosis.\n* Highly Successful Clinical Trial Results Advance Signature Mapping TBDx Solution to Operational Evaluation in South Africa (Dec 22 2010). Retrieved July 2, 2014 from\n\nhttp://www.advfn.com/news_Highly-Successful-Clinical-Trial-Results-Advance-S_45762842.html\n\n* Signature Mapping TBDxTM Demonstrates Positive Resulsts (June 21 2010). Retrieved July 2, 2014 from\n\nhttp://markets.financialcontent.com/pe/news/read?GUID=13537430\nSignature Mapping. Retrieved July 7, 2014 from http://66.147.244.245/~signaub4/?p=32.\n\n* health-e. \"Report: StatsSA Mortality, causes of death in South Africa 2011\" (Mar 21 2014). Retrieved July 2, 2014 from http://www.health-e.org.za/2014/03/21/report-statssa-mortality-causes-death-south-africa-2011/.\n\n== Video ==\n\n* Retrieved on Aug 18, 2014 from http://www.youtube.com/watch?v=DH9fKEjYSkE.\n\n{{Page data\n| sdg = SDG03 Good health and well-being, SDG09 Industry innovation and infrastructure\n| license = CC-BY-SA-3.0\n| language = en\n}}"}