On November 3rd, following the last session of the 44th Union World Conference on Lung Health, the team will pack-up the TBDx™ demonstration equipment and fly to Abuja, Nigeria, to start the second evaluation of our TBDx™ diagnostic platform. The project will be coordinated under the direction of four entities: the National Tuberculosis and Leprosy Control Program (NTBLCP), the Federal Capital Territory Tuberculosis and Leprosy Control Program (State counterpart of the NTBLCP and operates hospitals in 37 state districts), the Zankli Medical Center (ZMC) Research Laboratory, and the Liverpool School of Tropical Medicine (who has extensive experience in TB / HIV / Malaria research). Grant funding for the project has been provided by the European and Developing Countries Clinical Trials Partnership (EDCTP). The primary investigators will be Professor Luis Cuevas with the Liverpool School of Tropical Medicine, Dr. Joshua Obasanya of the NTBLCP, and Dr. Lovett Lawson of the Zankli Medical Center.
Also participating in the research study will be a new molecular diagnostic technology, Genedrive. Though having many features similar to Cepheid’s GeneXpert diagnostic assay, Genedrive is compact, operates on batteries, uses smaller cartridges that have a longer shelf life, and is expected to be less expensive. The Nigeria study will be the first independent evaluation of this new technology.
The Nigeria research protocol contains similarities to the recently completed evaluation in South Africa, though Genedrive will introduce new comparisons. Both platforms, TBDx™ and Genedrive, will evaluate adults symptomatic for TB who may or may not be co-infected with HIV. In all comparisons the study will assess the Sensitivity, Specificity, and Predictive values of each diagnostic method.
- The performance of TBDx™ will be directly compared with routine smear microscopy. Culture will be used as the reference standard.
- The performance of TBDx™ will be assessed as a screening technology whereby all TBDx™ positive cases will be confirmed by GeneXpert and by Genedrive. This “layered” diagnostic approach will be measured against the reference standard.
- The performance of GeneXpert and Genedrive will be directly compared against the reference standard.
- The cost saving impact of deploying the TBDx™ technology in Nigeria will be assessed.
Unlike the evaluation in South Africa where the APVS staff operated the TBDx™ system and provided the results to the laboratory staff, the Nigeria study presents an important opportunity to obtain research on how the system is operated by trained technicians in a typical laboratory routine. Once the TBDx™ system is set-up in the Zankli Medical Center, we will train the laboratory staff in the operations of the equipment and software, and they will operate it over a 3 month period. We will have connectivity to the system from the US to help troubleshoot operations should it be necessary, otherwise, the technicians will use the technology it in their daily laboratory routines.
Nigeria ranks 4thamong the 22 highest burdened TB countries in the world. It is estimated that over 450,000 new cases of TB occurred in the country last year. This problem is further compounded by the prevalence of HIV where it is estimated that 4.5% of the general population is infected. In this country of 154 million people, new diagnostic technologies are desperately needed. We look forward to the performance and operational evaluation, fully believing that deployment of our technology in Nigeria can make affordable and accurate diagnostic contributions that can stem the growth of tuberculosis.