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

Not yet recruiting

• Conditions: Tuberculosis, Extrapulmonary; Tuberculosis Active; Tuberculosis, Pulmonary
• Interventions: Device: NanoDetect-TB

• Registration Number: NCT05981495
• Lead Sponsor: NanoPin Technologies, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Last Update Submitted: 2023-07-31
• Study Start: 2023-08
• Study First Posted: 2023-08-08
• Last Update Posted: 2023-08-08
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 460

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TB Suspects	NanoDetect-TB	TB Suspects recruited to this study will have blood drawn in a single visit.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.