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Line Probe Assay Evaluation Study — YD  

Pulmonary Tuberculoses Clinical Trial

Official title:
Multi-center Study to Assess the Non-inferiority of YD REBA MTB-MDR® and Hain GenoType® MTBDRplus V2 Line Probe Assays Compared to Hain GenoType® MTBDRplus V1

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02984579
Study type Observational
Source Foundation for Innovative New Diagnostics, Switzerland
Contact
Status Completed
Phase N/A
Start date March 2015
Completion date January 2016
View Details
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