Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease

Study Overview
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Brief Summary
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The goal of this observational study is investigate the accuracy of the NanoDetect-TB kit in diagnosing tuberculosis (TB) using frozen serum and plasma samples collected from individuals suspected to have TB disease. The main question[s] it aims to answer are: How does this investigational device compare to the gold standard for TB diagnosis of sputum culture? How does it compare to Acid-Fast Bacteria (AFB) smear microscopy and FDA-approved NAAT TB diagnostic assays? Participants will be asked to have blood drawn and provide demographic and medical data for this study in a single visit.

Official Title
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Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease

Conditions
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Tuberculosis, Pulmonary, Tuberculosis, Extrapulmonary, Tuberculosis Active

Intervention / Treatment
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* Device: NanoDetect-TB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children and adults aged two years or older (including older adults that are 65+) Ability and willingness to provide informed consent/assent/permission, and a parent/legal guardian willing to give consent on the child's behalf for study participants aged 2-17 years Ability and willingness to perform study procedures, or parent/legal guardian to provide consent for a child to undergo study procedures on their behalf (when applicable) Clinical signs and symptoms typically associated with active TB disease including, but not limited to: Cough for > two (2) weeks Lethargy, weakness, malaise Reduced playfulness (pediatric population) Weight loss or loss of appetite Failure to thrive (pediatric population) Fever Chest pain Night sweats Physician (or healthcare provider) suspicion of TB disease Exclusion Criteria: Pregnancy (based on participant-provided information) Any physical or mental health condition for which participation in the study, as judged by the investigator, could compromise the well-being of the subject and/or prevent, limit, or confound protocol-specified procedures Critical illness needing immediate medical care Receipt of treatment for active TB or LTBI in the past 24 months

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TB Suspects<br>TB Suspects recruited to this study will have blood drawn in a single visit. | Device: NanoDetect-TB<br>* This study of the NanoDetect-TB investigational device will test plasma and serum samples from TB suspects. There is no intervention for the subjects and there will be a single visit blood draw.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NanoDetect-TB result compared to sputum culture | The investigational device results will be compared to the primary reference of sputum culture for determining relative sensitivity and specificity. | Single visit for patient for blood draw. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NanoDetect-TB result compared to AFB Smear and NAAT | The investigational device results will be further compared to the AFB Smear and NAAT for determining relative sensitivity and specificity. | Single visit for patient for blood draw. |