Line Probe Assay Evaluation Study (YD)

Foundation for Innovative New Diagnostics (FIND)

Status: Completed

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

Treatments: Device: Hain Genotype MTBDRplus V1; Device: YD REBA MTB-MDR; Device: Hain Genotype MTBDRplus V2

Study type: Observational

Funder types: Other

Identifiers

NCT02984579

YD7012-03

Details and patient eligibility

About

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.

Enrollment: 888 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

888 participants in 1 patient group

All Subjects

Description:

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.

Treatment:

Device: Hain Genotype MTBDRplus V2

Device: Hain Genotype MTBDRplus V1

Device: YD REBA MTB-MDR