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Assessment of Validity of the TB Host Response RUO Test Prototype for Diagnosis of Tuberculosis and Treatment Response

Assessment of Validity of the TB Host Response RUO Test Prototype for Diagnosis of Tuberculosis and Treatment Response

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100052491
Enrollment
Unknown
Registered
2021-10-29
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Tuberculosis

Interventions

Sponsors

School of Basic Medical Sciences, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Suspected tuberculosis patients aged 15 to 70 who visit the tuberculosis clinic of Wusheng County CDC. Fingertip blood samples should be collected at the same time point as sputum samples; 2. Diagnosed and newly diagnosed patient group: laboratory tests were positive for liquid culture and/or XpertMTB/RIF; 3. The sputum status in the test must be as accurate and reliable as possible; 4. If necessary, the results should be confirmed by repeated tests; 5. If TB culture is positive, exclude NTM samples from positive samples by MPT64; 6. Control group: patients who were treated at the TB clinic of the CDC but were excluded from tuberculosis.

Exclusion criteria

Exclusion criteria: Patients with tuberculosis who have received treatment for more than one month or have a history of tuberculosis. Patients who refuse to sign the informed consent form or who were deemed inappropriate by clinicians and investigators to participate in this study.

Design outcomes

Primary

MeasureTime frame
the validity of The TB Host Response RUO test prototype for diagnosis of TB patients;

Secondary

MeasureTime frame
the validity of The TB Host Response RUO test prototype for treatment response;

Countries

China

Contacts

Public ContactGao Qian

School of Basic Medical Sciences, Fudan University

qiangao@fudan.edu.cn+86 13671645425

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026