Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease
NanoPin Technologies, Inc.
Abstract
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.
MeSH terms
- Tuberculosis, Pulmonary
- Tuberculosis, Extrapulmonary
- Tuberculosis