Line Probe Assay Evaluation Study

Completed

• Conditions: Isoniazid Resistant Pulmonary Tuberculosis; Pulmonary Tuberculoses; Multidrug-Resistant Tuberculosis; Rifampicin Resistant Tuberculosis
• Interventions: Device: YD REBA MTB-MDR; Device: Hain Genotype MTBDRplus V1; Device: Hain Genotype MTBDRplus V2

• Registration Number: NCT02984579
• Lead Sponsor: Foundation for Innovative New Diagnostics, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Study First Submitted: 2016-11-30
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 888

Inclusion Criteria

• Age over 18 years
• Informed consent
• Patients evaluated for pulmonary TB

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Subjects	YD REBA MTB-MDR	All strains in Phase 1 and all Sputum samples in Phase 2 were tested with Hain Genotype MTBDRplus V1, Hain Genotype MTBDRplus V2, and YD REBA MTB-MDR diagnostic tests. Investigators and Operators were blinded to all other results for a sample upon data entry.
All Subjects	Hain Genotype MTBDRplus V2	All strains in Phase 1 and all Sputum samples in Phase 2 were tested with Hain Genotype MTBDRplus V1, Hain Genotype MTBDRplus V2, and YD REBA MTB-MDR diagnostic tests. Investigators and Operators were blinded to all other results for a sample upon data entry.
All Subjects	Hain Genotype MTBDRplus V1	All strains in Phase 1 and all Sputum samples in Phase 2 were tested with Hain Genotype MTBDRplus V1, Hain Genotype MTBDRplus V2, and YD REBA MTB-MDR diagnostic tests. Investigators and Operators were blinded to all other results for a sample upon data entry.

Primary Outcome Measures

Name	Time	Method
INH/RIF Resistance Detection	At the end of study 9-10 Months after the Study started

Secondary Outcome Measures

Name	Time	Method
Multi-Drug Resistant TB detection	At the end of study 9-10 Months after the Study started	Is the subject resistant to both INH and RIF