Line Probe Assay Evaluation Study

CompletedOBSERVATIONAL
Enrollment

888

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

January 31, 2016

Study Completion Date

January 31, 2016

Conditions
Multidrug-Resistant TuberculosisIsoniazid Resistant Pulmonary TuberculosisRifampicin Resistant TuberculosisPulmonary Tuberculoses
Interventions
DEVICE

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.

DEVICE

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

DEVICE

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

All Listed Sponsors
collaborator

Research Center Borstel

OTHER

collaborator

National Institute for Communicable Diseases, South Africa

OTHER

collaborator

Institute of Tropical Medicine, Belgium

OTHER

lead

Foundation for Innovative New Diagnostics, Switzerland

OTHER

NCT02984579 - Line Probe Assay Evaluation Study | Biotech Hunter | Biotech Hunter