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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
March 1, 2015
Primary Completion Date
January 1, 2016
Completion Date
January 1, 2016
Last Updated
February 14, 2017
888
ACTUAL participants
YD REBA MTB-MDR
DEVICE
Hain Genotype MTBDRplus V1
DEVICE
Hain Genotype MTBDRplus V2
DEVICE
Lead Sponsor
Foundation for Innovative New Diagnostics, Switzerland
Collaborators
Data Source & Attribution
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