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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


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

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