Prospective Assessment of TBDx Feasibility
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|ClinicalTrials.gov Identifier: NCT02912832|
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Tuberculosis||Device: TBDx||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||572 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||TBDx Feasibility Study: Prospective Study to Determine the Feasibility of Automated Smear Microscopy|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||August 2015|
All samples were tested with TBDx and compared with smear microscopy and Xpert MTB/RIF using solid and liquid culture as gold standard.
Operators were blinded to all other results for a sample upon data entry.
The TBDx is an automated platform is based on an Olympus BX41 microscope with a 40 x objective lens, fitted with an Olympus XC 10 colour camera and a movable slide stage, with an attached computer that receives high-quality digital images acquired from the camera. The computer then operates detection algorithms that segment, evaluate, and classify objects of interest in these images which can be stored for subsequent review. The platform is able to integrate an optional 200-slide automated slide loader for high volume settings. The application can capture 100, 300 or more digital fields-of-view and can provide results for positive or negative smears in 5 minutes or less.
Other Name: Automated microscopy
- Performance of TBDx compared to culture [ Time Frame: 6 months ]Sensitivity, specificity and predictive values of TBDx compared to two solid (Löwenstein Jensen) and two liquid (MGIT) cultures
- Training needs through questionnaire assessment [ Time Frame: 6 months ]Two days of hands-on, onsite TBDx training was provided to laboratory technicians with prior experience using smear microscopy, followed by 1-day observation. Each operator performed 3-4 runs under supervision and a proficiency assessment was conducted prior to study initiation. Following study completion all technicians were given a survey to assess perception of training needs and ease of use.
- Comparison of performance of TBDx on direct vs concentrated smear [ Time Frame: 6 months ]
- Performance of TBDx in combination with Xpert MTB/RIF through analysis of two different algorithms [ Time Frame: 6 months ]The performance of an algorithm combining direct TBDx as a triage test, followed by Xpert for confirmation of positive TBDx cases for the different cut-off points was assessed
- User appraisal regarding ease of use, hands-on-time and perceived benefit through appraisal questionnaire [ Time Frame: 6 months ]
- Identify potential difficulties for implementation through observation and user appraisal [ Time Frame: 6 months ]Potential barriers for implementation were assessed through observation and appraisal questionnaires following study completion, taking into account total time, complexity, number of steps, etc.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912832
|Instituto de Medicina Tropical Alexander von Humboldt - Universidad Peruana Cayetano Heredia|
|Pham Ngoc Thach Hospital|
|Ho Chi Minh City, Vietnam|
|Study Director:||Claudia M Denkinger, MD||Find|