It was the expectation of all vested parties that the clinical evaluation would begin no later than January 2014. We visited Nigeria in December, at which time TBDx™ was installed and training was provided to hospital laboratory technicians. From that point in time through mid-February the system has been undergoing “pre-evaluation” testing and validation.
During the pre-evaluation phase, the primary laboratory in Nigeria underwent an inspection by the Center for Disease Control. The inspector was particularly impressed by the performance of TBDx™. So much so that the inspector mentioned an interest in pursuing the suitability of the technology for deployment in Namibia.
The official start date was pushed back to February 14, 2014 due to the coordination of many external factors, such as:
- Setting up the network of external sputum collection sites,
- Development of quality control parameters,
- Development and modification of standard operating procedures (SOP’s) to accommodate the multiple new technologies,
- Delivery, installation and pre-testing of multiple new technologies, and
- Evaluation of the laboratory workflow.
We are delighted to report that the feedback we have been receiving from those individuals directly involved in the operation and integration of TBDx™ has been all positive. Dr. Luis Cuevas, the project leader, provided the following comment, “From my assessment, we seem to have established a satisfactory routine, roles of staff are well understood, responsibilities are clear to everybody, quality of sputum is now monitored routinely and specimens are repeated, if needed.” While this may seem disconnected to the performance of TBDx™, it is an extremely important component of the overall clinical evaluation of the system. Every laboratory system wants to understand how a new technology impacts their diagnostic protocols and effects laboratory operations. Dr. Cuevas’ comments indicate that the integration of TBDx™ has been relatively seamless. The more significant part of his comment is the impact that TBDx™ has had on the preparation and quality of the slides to be evaluated. Better, more consistent quality improves the diagnostic performance of TBDx™.
Now that the official evaluation has gotten underway, TBDx™ will be processing an increased volume amounting to hundreds of sputum samples per week. In addition, project leadership has decided to operate the TBDx™ system in full-automation mode by utilizing the TBDx™ bar code reading feature. Previously, and due to low volume whilst testing, slide ID’s were entered manually.
There are many private and public hospitals in Nigeria that will benefit from TBDx™ and the evaluation outcome. We will provide details on these opportunities as they unfold.
We are extremely excited that the evaluation has officially started and look forward to providing updates of the evaluation as permitted in the weeks and months ahead.