Evaluation of Non-Inferiority of Two Fast Follower Nucleic Acid Amplification Tests
- Conditions
- Tuberculosis
- Interventions
- Other: Epistem Genedrive® and MolBio Truenat™
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 504
-
• 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.
-
• 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
- Arm && Interventions
Group Intervention Description Investigational Epistem Genedrive® and MolBio Truenat™ • 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.
- 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 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;
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
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