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

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 Overview

• Status: Not yet recruiting
• Conditions: Tuberculosis, Pulmonary; Tuberculosis, Extrapulmonary; Tuberculosis Active
• Intervention / Treatment: Device: NanoDetect-TB

• Study Type: Observational
• Enrollment (Estimated): 460

Contacts and Locations

• Study Contact: Name: Thomas Tombler, Ph.D.; Phone Number: 18056800377; Email: ttombler@nanopintech.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TB Suspects; TB Suspects recruited to this study will have blood drawn in a single visit.	Device: NanoDetect-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Single visit for patient for blood draw.

Collaborators and Investigators

• Sponsor: NanoPin Technologies, Inc.
• Collaborators: Fortrea

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary; Tuberculosis, Extrapulmonary
• Other Study ID Numbers: NanoDetect-TB_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No