Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease

NanoPin Technologies

Status

Not yet enrolling

Conditions

Tuberculosis, Extrapulmonary

Tuberculosis Active

Tuberculosis, Pulmonary

Treatments

Device: NanoDetect-TB

Study type

Observational

Funder types

Industry

Identifiers

NCT05981495

NanoDetect-TB_01

Details and patient eligibility

About

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.

Enrollment

460 estimated patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

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