The team leaves Wednesday for Johannesburg, South Africa for an important evaluation of our TBDx technology that has been in the planning stages for the past several months. The evaluation will take place at the National Health Laboratory Services (NHLS) / Center for Tuberculosis from April 15 – May 2, 2012.
This will be a unique opportunity to demonstrate technology improvements made in the past year. Refinements in the detection algorithms have resulted in advancements in key diagnostic measurements (sensitivity and specificity), which has been reported previously on this blog.
Also, it is an opportunity to demonstrate how computer-vision technology can supplement routine microscopy and produce improvements in TB case findings, and illustrating the economic benefits of deploying TBDx as an effective screening technology.
Using culture, key comparisons will be made to assess the performance of TBDx, the increase in the volume of slide processing, the potential impact on labor and training budgets, the financial impact of combining two very different technologies, and measuring the speed from diagnosis to treatment.
The primary objectives of the protocol, approved by the NHLS and the London School of Tropical Medicine, are to:
- Evaluate the performance of the TBDx computer vision technology against the diagnostic performance of routine smear microscopy, using culture as the “gold” standard, and using GeneXpert to confirm positive TBDx findings.
- Measure the time-savings of the TBDx automated platform versus routine smear microscope
- Assess the cost-savings impact of the TBDx automated platform versus the human resource requirements of routine smear microscopy.
- Measure the economic impact for each positive case detection using TBDx as the front-end screening solution providing the positive detection cases to GeneXpert for confirmation and drug susceptibility testing
Several more weeks will be needed to compile the results, at which time a team will reassemble in South Africa and begin the analysis. We expect this test will illustrate significant cost savings using a layered diagnostic approach. Once this performance has been documented the next step will be to deploy TBDx and evaluate the daily workflow and use of the technology in select NHLS laboratory locations.
The results will be presented in an article to be submitted for publication in a peer-reviewed journal and presented to an appropriate industry conference.