TBDx.jpg
FA info icon.svg Angle down icon.svg Medical equipment data
Health topic Tuberculosis
Health classification Diagnosis
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Location Virginia, United States
Status Clinical trial
Instance of Microscopy diagnostic
OKH Manifest Download

Problem being addressed[edit | edit source]

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. The disease is also especially deadly to those with HIV.

Detailed description of the solution[edit | edit source]

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 | edit source]

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

When and where it was tested/implemented[edit | edit source]

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

Funding Source[edit | edit source]

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

References[edit | edit source]

Peer-reviewed publication[edit | edit source]

Other internally generated reports[edit | edit source]

Signature Mapping TBDxTM Technical Data Sheet. Retrieved 1 July, 2014 from http://tbevidence.org/documents/rescentre/sop/SMTBDX%20System%20Datasheet%20V11%20Automated.pdf

Externally generated reports[edit | edit source]

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 http://www.advfn.com/news_Highly-Successful-Clinical-Trial-Results-Advance-S_45762842.html

Signature Mapping TBDxTM Demonstrates Positive Resulsts (June 21 2010). Retrieved July 2, 2014 from http://markets.financialcontent.com/pe/news/read?GUID=13537430

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 http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0050173

IP and copyright[edit | edit source]

Approval by regulatory bodies or standards boards[edit | edit source]

FA info icon.svg Angle down icon.svg Page data
Part of Global Health Medical Device Compendium
SDG SDG03 Good health and well-being
Authors Caroline Soyars
License CC-BY-SA-3.0
Language English (en)
Related 0 subpages, 1 pages link here
Impact 276 page views
Created August 4, 2014 by Caroline Soyars
Modified November 23, 2022 by Irene Delgado
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