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

NCT02252198 | Completed

• 1 other identifier: NA_00085221
• Study Type: observational
• Target: 504
• Locations: 1 country
• Sites: 1

Brief 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

Tuberculosis

Outcome Measures

Primary Outcomes (3)

• Non-inferiority of tests

  Non-inferiority of Epistem Genedrive® MTB iD Test and MolBio Truenat™ TB Assay to GeneXpert MTB/RIF using a non-inferiority margin of 5% for sensitivity in smear-positive, culture-positive; 7% for overall C+ sensitivity; and 3% for specificity in smear-negative, culture-negatives

  4 months

• Sensitivity and specificity of Epistem Genedrive® MTB iD

  Sensitivity and specificity of Epistem Genedrive® MTB iD Test on raw sputum before homogenization, homogenized raw sputum and sputum pellet against a gold standard of concentrated smear and four cultures.

  4 months

• Sensitivity and specificity of MolBio Truenat™ TB Assay

  Sensitivity and specificity of MolBio Truenat™ TB Assay on homogenized raw sputum and sputum pellet against a gold standard of concentrated smear and four cultures.

  4 months

Secondary Outcomes (4)

• Failure rate for the Epistem Genedrive® system assay and for the MolBio Truenat™ assay

  10 months

• Training needs for each assay

  10 months

• Operational feasibility

  10 months

• Cost-comparison between assays

  10 months

Study Arms (1)

Investigational

• Participants will be asked to provide a total of three sputum samples over Days 1 and 2. The intent is for all samples to be collected before the subject starts any form of TB treatment. The first specimen (S1) should be 2 ml or greater in volume, and the second and third specimens (S2 and S3) should each be 1 ml or greater in volume. On Day 1, each participant will be asked to submit one spot sputum (S1) after enrollment and a second spot sputum after at least 2 hours (S2). Participants will be instructed to come back the following day (Day 2) and provide a third spot sputum (S3). In the event that a participant fails to return on Day 2, S3 may be collected a maximum of 7 days after enrollment, provided that no TB treatment has been initiated.

Other: Epistem Genedrive® and MolBio Truenat™

Interventions

Epistem Genedrive® and MolBio Truenat™ OTHER

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™.

Investigational

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

Adults with clinical suspicion of pulmonary TB.

You may qualify if:

• Clinical suspicion of pulmonary TB (including cough ≥2 weeks and at least 1 other symptom typical of TB);
• Age 18 years or above;
• Willingness to have a study follow-up visit, if necessary, approximately two months after enrollment
• Willingness to provide 3 sputum specimens at enrollment
• Provision of informed consent.

You may not qualify if:

• Receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment (defined as combination anti-TB therapy intended to treat active TB) within 60 days prior to completion of sputum collection;
• Inability to provide informed consent (e.g. mentally impaired)

Sponsors & Collaborators

• Johns Hopkins University: lead
• Boston Medical Center: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Inbaraj LR, Daniel J, Sathya Narayanan MK, Srinivasalu VA, Bhaskar A, Scandrett K, Rajendran P, Kirubakaran R, Shewade HD, Malaisamy M, Padmapriyadarsini C, Takwoingi Y. Truenat MTB assays for pulmonary tuberculosis and rifampicin resistance in adults and adolescents. Cochrane Database Syst Rev. 2025 Mar 24;3(3):CD015543. doi: 10.1002/14651858.CD015543.pub2.

  PMID: 40122135 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 30, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: December 12, 2017

Record last verified: 2017-12

Locations

US (1)