Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease
Study Details
Study Description
Brief Summary
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:
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How does this investigational device compare to the gold standard for TB diagnosis of sputum culture?
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| TB Suspects TB Suspects recruited to this study will have blood drawn in a single visit. |
Device: NanoDetect-TB
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.
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Outcome Measures
Primary Outcome Measures
- NanoDetect-TB result compared to sputum culture [Single visit for patient for blood draw.]
The investigational device results will be compared to the primary reference of sputum culture for determining relative sensitivity and specificity.
Secondary Outcome Measures
- NanoDetect-TB result compared to AFB Smear and NAAT [Single visit for patient for blood draw.]
The investigational device results will be further compared to the AFB Smear and NAAT for determining relative sensitivity and specificity.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Children and adults aged two years or older (including older adults that are 65+)
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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
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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)
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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:
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Pregnancy (based on participant-provided information)
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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
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Critical illness needing immediate medical care
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Receipt of treatment for active TB or LTBI in the past 24 months
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- NanoPin Technologies, Inc.
- Fortrea
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NanoDetect-TB_01