Prospective Assessment of TBDx Feasibility

Foundation for Innovative New Diagnostics (FIND)

Status: Completed

Conditions: Pulmonary Tuberculosis

Treatments: Device: TBDx

Study type: Interventional

Funder types: Other

Identifiers

NCT02912832

7012-05-3/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 572 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

---

572 participants in 1 patient group

TBDx

Experimental group

Description:

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.

Treatment:

Device: TBDx