TBDx Clinical Trials Update

The clinical research trials for TBDx are now completed. They remained open until all of the analyses had been completed by the Principal Investigator. Now that the analysis is completed, we will be receiving the “truth” files from the Aurum Institute and can begin additional analysis which, although outside of the study, will contribute to better detection algorithms in the next iteration of the technology.

The Conference Committee for the 42nd Union World Conference on Lung Disease has solicited abstracts of new technology initiatives in TB that can be presented in a dedicated high profile “late breaker” conference session. The Principal Investigator and members of the Scientific Advisory Board have completed and submitted an abstract for this session describing the performance results of the TBDx research trials. We hope to hear by the end of the month if our abstract was accepted for presentation.

Additionally the Principal Investigator is drafting the paper that will be submitted describing the clinical trial and the technology performance results. This paper is intended to be submitted to the Public Library of Science (http://www.plos.org/). There are several advantages in submitting the paper to the PLoS. First, this is an electronic media source and accepted research can be published much faster than printed media, once the international peer review has been completed and the paper accepted. Secondly this source of scientific information is more accessible to the primary audience interested in our research. Thirdly, it is viewed by a wide spectrum of infectious disease professionals as a valuable source for the most current scientific research. We intend to have the paper written and submitted prior to the Union conference in October.

As is the protocol for this clinical research all performance results are embargoed until they can be publicly presented to the scientific community. We wish we could provide more details. However, we can say that TBDx promises a substantial impact on the workload and screening for TB in the South Africa and, eventually, around the world.

Initiatives in South Africa
Now that the clinical trial has been completed the intent is to finalise the deployment of the TBDx technology in the National TB Reference Laboratory. After the lab decides on the overall workflow for the the technology, operational use will begin as part of their “Re-check” or Quality Assurance program. TBDx will be the first “control”. Once the technology has made its assessments, a second assessment of Scanty TB cases will be reviewed by a microbiologist. It is expected that by deploying TBDx the number of cases and Fields of View that would be seen by the microbiologist would be substantially reduced, having dramatic impact on the labs workload. The system has already been procured by the Aurum Institute and placed at the NHLS.

Once the Re-check deployment has been completed, the next intended step will be to deploy the technology in a “demonstration project” at the Braamfontein high-volume laboratory. This operational assessment of the technology will focus on performance in a setting that receives up to 3,000 specimens per week. The project protocol has been created and accepted.

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