One very important hallmark, in any technology evaluation, is the ability to consistently produce similar results across multiple independent tests. Can the performance of TBDx™ in external laboratory tests match its’ performance during internal tests? Can this technology play a role in TB diagnostics? We asked Dr. David Clark, Deputy CEO of the Aurum Institute, one of the collaborating institutional researchers, if he could provide his impressions of the study results to-date. Here are his thoughts:
Researchers working with APVS set out to evaluate performance of the system in a high volume setting against the ‘gold standard’ of organism culture. The evaluation aimed at investigating the performance of TBDx™ as a diagnostic, but also the possible impact of using TBDx™ as a front-end screening application to other diagnostic modalities.
Use of TBDx™ on over 1,100 sputum specimens from a high volume setting, together with matching organism culture results, has been completed and data is in the process of being cleaned and finalized. This data will enable credible measurement of the sensitivity and specificity of TBDx™ in high volume settings and provide important input to an economic analysis model being developed by leading TB modeling scientists in the field.
Preliminary calculations on the data thus far are particularly encouraging and researchers from South Africa and the USA are engaged in finalizing their investigations with a view to publication, as soon as possible.
From October 30 to November 3, 2013 the 44th World Conference on Lung Health will be held in Paris, France. This is the industry’s premier educational conference where new research findings are announced. An effort is underway to submit an abstract, by the end of July, of the evaluation results for consideration in the “Late Breaker” session. The session will feature a panel presentation on the latest in diagnostic research results. This is a very competitive process, with hundreds of abstracts submitted for consideration. We are hopeful the abstract will be accepted.