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

Johns Hopkins University504 enrolled

Overview

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

* 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 Type

OBSERVATIONAL

Enrollment

504

Conditions

Tuberculosis

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™.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Johns Hopkins University

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 4 months

Secondary Outcomes

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

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

Time frame: 10 months

Training needs for each assay

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

Time frame: 10 months

Operational feasibility

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.