Last week Applied Visual Sciences moved one step closer to securing a World Health Organization (WHO) endorsement for TBDx™. Along with our collaboration partner, FIND (Foundation for Innovative New Diagnostics), we installed and trained the management, microbiologists, and laboratory technicians at the Pham Ngoc Thach Tuberculosis and Lung Disease Hospital in Ho Chi Minh City, Vietnam. This particular TB laboratory conducts an extremely high volume, anywhere from 700 to 1,000 slides per day using a staff of eight (8) laboratory technicians.
The primary objectives of this study do not deviate materially from our previous studies in South Africa, Nigeria, and Peru.
- Determine the sensitivity, specificity, and predictive values of TBDx™ among adult TB suspects, using culture as the gold standard;
- Compare the performance of TBDx™ to routine laboratory LED fluorescent microscopy (LED/FM); and,
- Determine the feasibility of using TBDx™ at a high workload reference laboratory.
The secondary objectives of the study are as follows:
- Determine the minimal training requirements;
- Determine the time-to-diagnosis compared to routine LED/FM;
- Assess performance variations between direct and concentrated smears;
- Determine the performance of TBDx™ as a lead-in triage to Xpert MTB/RIF;
- Assess the ease-of-use, hands-on time and perceived benefits; and,
- Identify potential challenges to implementation.
Tosh Sondh, APVS Director of Engineering, conducted the kickoff meeting with the study team officials and installed TBDx™ in the laboratory. Over the succeeding 4-day period he conducted extensive training sessions with the laboratory Director, Dr. Hang, the laboratory Deputy Director, Dr. Ha, and the full laboratory staff. The training, when combined with the APVS provided Field Manuals, will assist in the successful execution of the study project. The TBDx™ system is connected to the Internet to assist in remote troubleshooting, if necessary.
It is anticipated that the clinical study fieldwork will complete within approximately 30 days. At that time data will be accumulated, analyzed, and reported. That data will form the basis of a publishable article on the performance of TBDx™, as well as add to the mounting data already collected in support of WHO endorsement.
Initial impressions from laboratory personnel were extremely favorable. Dr. Ha, in particular, immediately understood the benefits of automating the diagnostic process thereby reducing human factors limitations, and allowing laboratory staff to be reassigned to other high value assignments.