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

CompletedOBSERVATIONAL
Enrollment

504

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

January 31, 2015

Study Completion Date

January 31, 2015

Conditions
Tuberculosis
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™.

Trial Locations (1)

21287

Johns Hopkins University, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Boston Medical Center

OTHER

lead

Johns Hopkins University

OTHER