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

Completed

• Conditions: Tuberculosis

• Registration Number: NCT02252198
• Lead Sponsor: Johns Hopkins University

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

Detailed Description

* Estimate the accuracy of the Epistem Genedrive® and MolbioTruenat™ in raw sputum and in sputum pellets.

* Assess the operational feasibility of Epistem Genedrive® and MolbioTruenat™

* Determine and compare costs between the Epistem Genedrive®, MolbioTruenat™, and Xpert MTB/RIF tests

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-30
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-08
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 504

Inclusion Criteria

• • 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.

Exclusion Criteria

• • 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)
  • Enrolled individuals who do not provide a first sputum sample of ≥ 2ml and a second and third sputum sample of ≥ 1ml each will be classified as early exclusions.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of Epistem Genedrive® MTB iD	4 months	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.
Non-inferiority of tests	4 months	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
Sensitivity and specificity of MolBio Truenat™ TB Assay	4 months	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.

Secondary Outcome Measures

Name	Time	Method
Failure rate for the Epistem Genedrive® system assay and for the MolBio Truenat™ assay	10 months	Failure rate for the Epistem Genedrive® system assay and for the MolBio Truenat™ assay, expressed as the proportion of tests that require repeating due to an indeterminate or uninterpretable initial result (separately and together for tests performed on raw sputum and sputum pellet
Operational feasibility	10 months	Operational feasibility will be assessed according to the infrastructure required to support each test, the robustness of the reagents and equipment (any breakdowns, storage requirements or contamination events), and the time it takes to run each test;
Training needs for each assay	10 months	Training needs for each assay assessed objectively by number of hours of training, number of runs required, and successful completion of a proficiency assessment by trainees; training needs also will be assessed subjectively by the trainers and by user questionnaires
Cost-comparison between assays	10 months	A cost-comparison between assays assessing the cost per sample run incorporating all costs involved in transport, equipment, reagents, personnel, etc. will be performed.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States