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Evaluating the Accuracy of New Tests for TB Infection Diagnosis

NCT06221735 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2025-03-19

No results posted yet for this study

Summary

Introduction: The large reservoir of tuberculosis infections is a key driver of sustained tuberculosis (TB) incidence. Accurate diagnostic tests are crucial to correctly identify and treat people with TB infection, which is vital to eliminate TB globally. The Cy-TB skin test and STANDARD F TB-Feron FIA (TB-Feron) fluorescent immunoassay are two newly developed TB infection tests, which could offer quality and cost advantages over other commercially available TB infection tests, especially the standard TST test. Both tests have a higher sensitivity and specificity than the currently most used tuberculin skin test. The proposed study aims to evaluate the performance of these two tests for the diagnosis of TB infection, compared with the QuantiFERON-TB Gold Plus (QFT-Plus) assay.

Methods and analysis: This diagnostic accuracy study will employ a cross-sectional, observational design that aims to assess the accuracy of the Cy-TB and TB-Feron tests for diagnosing TB infection, using the QFT-Plus assay as the reference standard. The sensitivity and specificity will be reported. Three different cohorts of study participants will be recruited: Adults with microbiologically-confirmed pulmonary TB (n=100); Household contacts\* of people with TB (n=200) and negative controls\*\* (n=50). All participants will be examined with Cy-TB, TB-Feron, and QFT-Plus.

\*Household contacts: of a person with TB are defined as members who live under the same roof as the person with pulmonary tuberculosis (PTB) or who meet the following conditions:

* Sleeping under the same roof or sharing a kitchen space as PTB-affected persons at least one night/week for three months before the person was diagnosed with PTB
* Staying under the same roof with PTB-affected persons for at least one hour/day and continuously five days/week for three months before the person was diagnosed with PTB

* Negative controls are defined as people with a negative QFT-Plus result in the past year and likely to have no or very low rates of TB exposure history.

Conditions

Interventions

DIAGNOSTIC_TEST

Cy-TB test

The study will include people with confirmed TB infection and negative controls to compare the specificity and sensitivity of the Cy-TB and TB-Feron tests versus the QFT-Plus assay

DIAGNOSTIC_TEST

STANDARD F TB-Feron FIA test

The study will include people with confirmed TB infection and negative controls to compare the specificity and sensitivity of the Cy-TB and TB-Feron tests versus the QFT-Plus assay

Sponsors & Collaborators

  • Freundeskreis Für Internationale Tuberkulosehilfe e.V

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-11
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

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 NCT06221735 on ClinicalTrials.gov