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Development of Molecular Diagnostic Platform for Tuberculosis

Development of a Rapid and Accurate Diagnostic Assay for Tuberculosis by Using New Sample Preparation and Detection Technique

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04734236
Enrollment
200
Registered
2021-02-02
Start date
2021-01-28
Completion date
2021-12-31
Last updated
2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Brief summary

This study evaluates new technique for diagnosis of tuberculosis. Among patients who are suspected with tuberculosis, participants will be tested conventional method including Xpert TB/RIF assay, and new diagnostic technique using homobifunctionalImidoesters compounds.

Interventions

DIAGNOSTIC_TESTNew technique vs Xpert

New technique vs Xpert

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients who are suspected with pulmonary tuberculosis, tuberculosis meningitis, tuberculosis peritonitis, tuberculosis pleurisy

Exclusion criteria

* Under 18 years

Design outcomes

Primary

MeasureTime frameDescription
The effectiveness of new diagnostic techniqueTime Frame: An average of 2 yearsensitivity and specificity of new test

Countries

South Korea

Contacts

Primary ContactSeiwon Lee
iseiwon@gmail.com82-10-3010-3990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026