Prospective Assessment of TBDx Feasibility

NCT ID: NCT02912832

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 572 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-08-31

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.

Conditions

Pulmonary Tuberculosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

TBDx

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Automated microscopy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Innovative New Diagnostics, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudia M Denkinger, MD

Role: STUDY_DIRECTOR

Find

Locations

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

Lima, , Peru

Pham Ngoc Thach Hospital

Ho Chi Minh City, , Vietnam

Countries

Peru; Vietnam

Related Links

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0050173

TBDx Proof of concept

http://www.atsjournals.org/doi/abs/10.1164/rccm.201502-0390OC?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed&#.V9LnfPl97RY

TBDx performance South Africa

Other Identifiers

7012-05-3/1

Identifier Type: -

Identifier Source: org_study_id