Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Johns Hopkins University
With
Boston Medical Center
* 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
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
* 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.
Clareo Health | Evaluation of Non-Inferiority of Two Fast Follower Nucleic Acid Amplification Tests
