888
Participants
Start Date
March 31, 2015
Primary Completion Date
January 31, 2016
Study Completion Date
January 31, 2016
YD REBA MTB-MDR
Conducted on stored, de-identified leftover samples. A line probe assay designed for detection of Multidrug-resistant tuberculosis (MDR-TB). The REBA MTB-MDR® assay is a qualitative in vitro test for the identification of Mycobacterium tuberculosis (MTB) complex and its susceptibility to rifampin and isoniazid from cultured samples and smear positive specimens.
Hain Genotype MTBDRplus V1
Conducted on stored, de-identified leftover samples. There is only one Line Probe Assay for molecular MTB drug resistance globally available, the GenoType® MTBDRplus V.1 from Hain Lifescience. This assay includes rpoB gene probes for Rifampin (RIF) resistance, katG gene probes for high level Isoniazid (INH) resistance, and inhA gene probes for determination of low level INH resistance
Hain Genotype MTBDRplus V2
Conducted on stored, de-identified leftover samples. An updated version of the Hain Genotype MTBDRplus V1 assay, the Genotype MTBDRplus V.2 line probe assay, showed increased sensitivity for MTB detection in the 2 studies published so far
Research Center Borstel
OTHER
National Institute for Communicable Diseases, South Africa
OTHER
Institute of Tropical Medicine, Belgium
OTHER
Foundation for Innovative New Diagnostics, Switzerland
OTHER