Line Probe Assay Evaluation Study

Conditions: Multidrug-Resistant Tuberculosis, Isoniazid Resistant Pulmonary Tuberculosis, Rifampicin Resistant Tuberculosis, Pulmonary Tuberculoses

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Enrollment: 888

Sponsor: Foundation for Innovative New Diagnostics, Switzerland

Summary

This is a multi-center, blinded study to determine the performance of the YD Diagnostic Corporation (YD) REBA MTB-MDR® and Hain Genotype MTBDRplus V2 kit in a total of 600 clinical isolates and 900 residual sputum samples from patients with symptoms of pulmonary TB (PTB) and at risk of drug resistance. All testing was done on stored, de-identified leftover samples. The study involved three World Health Organization (WHO) Supranational Reference Laboratories with well-characterized strain collections and access to sputum samples with significant rates of drug resistance.

Eligibility Criteria

Inclusion Criteria: * Age over 18 years * Informed consent * Patients evaluated for pulmonary TB Exclusion Criteria: \-

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02984579). StuddyBuddy aggregates publicly available trial information.