TBDx

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

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.

Funding Source

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

References

Peer-reviewed publication

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

Other internally generated reports

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

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

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