Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Research Center Borstel | OTHER |
| National Institute for Communicable Diseases, South Africa | OTHER |
| Institute of Tropical Medicine, Belgium | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects | All strains in Phase 1 and all Sputum samples in Phase 2 were tested with Hain Genotype MTBDRplus V1, Hain Genotype MTBDRplus V2, and YD REBA MTB-MDR diagnostic tests. Investigators and Operators were blinded to all other results for a sample upon data entry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YD REBA MTB-MDR | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| INH/RIF Resistance Detection | At the end of study 9-10 Months after the Study started |
| Measure | Description | Time Frame |
|---|---|---|
| Multi-Drug Resistant TB detection | Is the subject resistant to both INH and RIF | At the end of study 9-10 Months after the Study started |
Not provided
Inclusion Criteria:
Exclusion Criteria:
-
Not provided
Not provided
Not provided
The study consisted of two phases. In phase 1, each site was sent a different set of 200 clinical isolates from the Research and Training in Tropical Diseases and Institute for Tropical Medicine collections (ITM).
In phase 2, samples from 274 patients recruited between Azerbaijan and Moldova were tested in Germany, while samples from 214 (locally-recruited) patients were tested in South Africa.
Not provided
| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Hain Genotype MTBDRplus V1 | Device | 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 | Device | 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 |
|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |