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Completed

NCT Number: NCT02984579

Line Probe Assay Evaluation Study

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.

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Key information

Conditions

Multidrug-resistant Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Isoniazid Resistant Pulmonary Tuberculosis Lung Diseases Mycobacterium Infections Pulmonary Tuberculoses Respiratory Tract Diseases Respiratory Tract Infections Rifampicin Resistant Tuberculosis Tuberculosis Tuberculosis, Multidrug-Resistant Tuberculosis, Pulmonary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

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.

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

Primary outcomes

  1. INH/RIF Resistance Detection

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

Secondary outcomes

  1. Multi-Drug Resistant TB detection

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

    Is the subject resistant to both INH and RIF

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Collaborators

  • Institute of Tropical Medicine, Belgium
  • National Institute for Communicable Diseases, South Africa
  • Research Center Borstel

Registry information

Official study title

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

Acronym: YD

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 7, 2016
Registry last updated
Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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