Trials / Unknown
UnknownNCT05981495
Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 460 (estimated)
- Sponsor
- NanoPin Technologies, Inc. · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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: * 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-08-01
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2023-08-08
- Last updated
- 2023-08-08
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05981495. Inclusion in this directory is not an endorsement.