Trials / Completed
CompletedNCT02984579
Line Probe Assay Evaluation Study
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 888 (actual)
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Multidrug-Resistant Tuberculosis
- Isoniazid Resistant Pulmonary Tuberculosis
- Rifampicin Resistant Tuberculosis
- Pulmonary Tuberculoses
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2016-01-01
- Completion
- 2016-01-01
- First posted
- 2016-12-07
- Last updated
- 2017-02-14
Source: ClinicalTrials.gov record NCT02984579. Inclusion in this directory is not an endorsement.