Isoniazid Resistant Pulmonary Tuberculosis, Multidrug-Resistant Tuberculosis, Pulmonary Tuberculoses, Rifampicin Resistant Tuberculosis
Conditions
Brief 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.
Interventions
DEVICEYD 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.
DEVICEHain 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
DEVICEHain 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
Sponsors
Foundation for Innovative New Diagnostics, Switzerland
Research Center Borstel
National Institute for Communicable Diseases, South Africa
Institute of Tropical Medicine, Belgium
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 18 years * Informed consent * Patients evaluated for pulmonary TB
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| INH/RIF Resistance Detection | At the end of study 9-10 Months after the Study started |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multi-Drug Resistant TB detection | At the end of study 9-10 Months after the Study started | Is the subject resistant to both INH and RIF |
Outcome results
None listed