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.
Study Type
OBSERVATIONAL
Enrollment
460
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.
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.
Time frame: Single visit for patient for blood draw.
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.
Time frame: Single visit for patient for blood draw.
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