Line Probe Assay Evaluation Study

NCT02984579 | Completed

• 1 other identifier: YD7012-03
• Study Type: observational
• Target: 888
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multidrug-Resistant Tuberculosis; Isoniazid Resistant Pulmonary Tuberculosis; Rifampicin Resistant Tuberculosis; Pulmonary Tuberculoses

Outcome Measures

Primary Outcomes (1)

• INH/RIF Resistance Detection

  At the end of study 9-10 Months after the Study started

Secondary Outcomes (1)

• Multi-Drug Resistant TB detection

  At the end of study 9-10 Months after the Study started

Study Arms (1)

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.

Device: YD REBA MTB-MDR; Device: Hain Genotype MTBDRplus V1; Device: Hain Genotype MTBDRplus V2

Interventions

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.

All Subjects

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

All Subjects

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

All Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age over 18 years
• Informed consent
• Patients evaluated for pulmonary TB

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• Research Center Borstel: collaborator
• National Institute for Communicable Diseases, South Africa: collaborator
• Institute of Tropical Medicine, Belgium: collaborator

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant; Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 7, 2016
• Study Start: March 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 14, 2017

Record last verified: 2017-02