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This Global Health Medical Device is designed for or implemented within resource-limited settings - Browse the devices - Add a device

Health Topic Tuberculosis
Classification Diagnosis
Scope Clinical trial
Location Africa

Problem being addressed[edit]

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[edit]

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. (

Designed by[edit]

  • Designed by: Signature Mapping Medical Sciences, Inc.
  • Manufacturer (if different): Guardian
  • Manufacturer location: Virginia, USA

When and where it was tested/implemented[edit]

The TBDx held clinical trials in South Africa, and the Aurum Institute for Health Research ordered three TBDx systems in 2011.

Funding Source[edit]

US President’s Emergency Plan for AIDS Relief (PEPFAR)


Peer-reviewed publication[edit]

  • 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[edit]

  • Signature Mapping TBDxTM Technical Data Sheet. Retrieved 1 July, 2014 from

Externally generated reports[edit]

  • 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 Signature Mapping. Retrieved July 7, 2014 from