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Line Probe Assay Evaluation Study

NCT02984579 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 888

Last updated 2026-09-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Research Center Borstel

    collaborator OTHER

  • National Institute for Communicable Diseases, South Africa

    collaborator OTHER

  • Institute of Tropical Medicine, Belgium

    collaborator OTHER

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-01-31
Completion
2016-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02984579 on ClinicalTrials.gov