Tuberculosis Active, Tuberculosis, Extrapulmonary, Tuberculosis, Pulmonary
Conditions
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: * 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.
Interventions
DEVICENanoDetect-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.
Sponsors
Fortrea
NanoPin Technologies, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactThomas Tombler, Ph.D.
Outcome results
None listed