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Problem being addressed
With 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$), TB is prevalent in resource-limited settings. To prevent the spreading of this disease, accurate, efficient, and quick diagnosis is required.
Detailed description of the solution
TBDx is a fully automated sputum smear (mucus) microscopy diagnostic solution for the detection of TB. It adds image processing to the routine smear microscopy, has a step-by-step guide for setup and process initialization, utilizes touchscreen capabilities and simple to understand features, and can support up to a 200-slide autoloader system for higher production environments. These features, combined with a lower cost-per-slide (~2.50$ 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).
- Designed by: Signature Mapping Medical Sciences, Inc.
- Manufacturer (if different): Guardian
- Manufacturer location: Virginia, USA
When and where it was tested/implemented
The TBDx held clinical trials in South Africa, and the Aurum Institute for Health Research ordered three TBDx systems in 2011.
US President’s Emergency Plan for AIDS Relief (PEPFAR)
- 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
Other internally generated reports
- Signature Mapping TBDxTM Technical Data Sheet. Retrieved 1 July, 2014 from
Externally generated reports
- 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.
- 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.
- Highly Successful Clinical Trial Results Advance Signature Mapping TBDx Solution to Operational Evaluation in South Africa (Dec 22 2010). Retrieved July 2, 2014 from
- Signature Mapping TBDxTM Demonstrates Positive Resulsts (June 21 2010). Retrieved July 2, 2014 from
http://markets.financialcontent.com/pe/news/read?GUID=13537430 Signature Mapping. Retrieved July 7, 2014 from http://18.104.22.168/~signaub4/?p=32.
- 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/.
- Retrieved on Aug 18, 2014 from http://www.youtube.com/watch?v=DH9fKEjYSkE.