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

NCT05981495 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 460

Last updated 2023-08-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Fortrea

    collaborator INDUSTRY

  • NanoPin Technologies, Inc.

    lead INDUSTRY

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05981495 on ClinicalTrials.gov