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Completed

NCT Number: NCT02912832

Prospective Assessment of TBDx Feasibility

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.

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Key information

Conditions

Pulmonary Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Disease Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis Tuberculosis, Pulmonary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Medicina Tropical Alexander von Humboldt - Universidad Peruana Cayetano Heredia, Lima, Peru

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TBDx

Device

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 names: Automated microscopy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Comparison of performance of TBDx on direct vs concentrated smear

    Time frame: 6 months

  3. 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

  4. User appraisal regarding ease of use, hands-on-time and perceived benefit through appraisal questionnaire

    Time frame: 6 months

  5. 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.

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Registry information

Official study title

TBDx Feasibility Study: Prospective Study to Determine the Feasibility of Automated Smear Microscopy

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 23, 2016
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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