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Prospective Assessment of TBDx Feasibility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02912832
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Information provided by (Responsible Party):
Foundation for Innovative New Diagnostics, Switzerland

Tracking Information
First Submitted Date  ICMJE September 9, 2016
First Posted Date  ICMJE September 23, 2016
Last Update Posted Date September 23, 2016
Study Start Date  ICMJE October 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Prospective Assessment of TBDx Feasibility
Official Title  ICMJE TBDx Feasibility Study: Prospective Study to Determine the Feasibility of Automated Smear Microscopy
Brief Summary The purpose of this study will be to determine the performance characteristics of TBDx with culture as a gold standard. In addition, the investigators will assess the laboratory technicians' appraisal and technical suitability of the TBDx system.
Detailed Description This will be a blinded, prospective study to determine the performance of the TBDx system for detection of pulmonary TB in comparison to LED microscopy and culture as a gold standard. The study will involve recruitment of 300 TB suspects per site with a high workload and experienced technicians. Participants will be recruited under the FIND TB Reference Materials project and leftover sputum samples used for the assessment of the TBDx.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Pulmonary Tuberculosis
Intervention  ICMJE Device: TBDx
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
Study Arms  ICMJE Experimental: TBDx

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.

Intervention: Device: TBDx
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2016)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Persistent cough (>2 weeks) and at least one other typical symptom of pulmonary TB (fever, night sweats, malaise, recent weight loss, contact with active case, hemoptysis, chest pain, loss of appetite)
  • Provision of informed consent (FIND TB Reference Materials)
  • Provision of sputum for adequate testing

Exclusion Criteria:

  • Patients receiving any anti-TB medication, in the 60 days prior to testing.
  • Patients with only extra-pulmonary disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Peru,   Vietnam
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02912832
Other Study ID Numbers  ICMJE 7012-05-3/1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified patient and results dataset will be made available upon publication of study findings
Responsible Party Foundation for Innovative New Diagnostics, Switzerland
Study Sponsor  ICMJE Foundation for Innovative New Diagnostics, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Claudia M Denkinger, MD Find
PRS Account Foundation for Innovative New Diagnostics, Switzerland
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP