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

NCT05981495 | Unknown FDA Device

• 1 other identifier: NanoDetect-TB_01
• Study Type: observational
• Target: 460
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tuberculosis, Pulmonary; Tuberculosis, Extrapulmonary; Tuberculosis Active

Outcome Measures

Primary Outcomes (1)

• 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.

  Single visit for patient for blood draw.

Secondary Outcomes (1)

• NanoDetect-TB result compared to AFB Smear and NAAT

  Single visit for patient for blood draw.

Study Arms (1)

TB Suspects

TB Suspects recruited to this study will have blood drawn in a single visit.

Device: NanoDetect-TB

Interventions

NanoDetect-TB DEVICE

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.

TB Suspects

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

TB suspects at clinical sites for recruitment in Houston, Miami, and New York City.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NanoPin Technologies, Inc.: lead
• Fortrea: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and Serum samples

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Tuberculosis, Extrapulmonary; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Thomas Tombler, Ph.D.

CONTACT

18056800377; ttombler@nanopintech.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 8, 2023
• Study Start: August 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 8, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share