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Evaluation of Non-Inferiority of Two Fast Follower Nucleic Acid Amplification Tests

NCT02252198 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 504

Last updated 2017-12-12

No results posted yet for this study

Summary

Assess sensitivity and specificity of two nucleic acid amplification tests, namely Epistem Genedrive® and MolbioTruenat™ in raw sputum compared to the WHO-endorsed GeneXpert® MTB/RIF assay using a gold standard of four cultures

Conditions

Interventions

OTHER

Epistem Genedrive® and MolBio Truenat™

S1 will undergo direct smear and Epistem Genedrive® (optional for phase 2\*) testing, before being homogenized with glass beads and split into three portions for testing with Epistem Genedrive®, MolBio Truenat™ and GeneXpert MTB/Rif® respectively. S2 and S3 will be randomized as to the order of testing using Epistem Genedrive® and MolBio Truenat™.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT02252198 on ClinicalTrials.gov