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Clinical Evaluation of a TB-LAMP Diagnostic Kit for Mycobacterium tuberculosis Complex Using Tongue Swab Specimens for the Diagnosis of Pulmonary Tuberculosis

Clinical Evaluation of a TB-LAMP Diagnostic Kit for Mycobacterium tuberculosis Complex Using Tongue Swab Specimens for the Diagnosis of Pulmonary Tuberculosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600131702
Enrollment
Unknown
Registered
2026-09-05
Start date
2026-02-23
Completion date
Unknown
Last updated
2026-09-07

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

Conditions

tuberculosis disease

Interventions

Sponsors

Beijing Chest Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. Meets clinical diagnostic criteria for suspected tuberculosis (TB), including typical symptoms such as persistent cough, expectoration, fever, night sweats, and weight loss, as well as abnormal pulmonary imaging findings on chest X-ray or CT scans; 3. No prior anti-TB treatment before the study commencement, or has discontinued treatment for at least two weeks; 4. For non-TB respiratory patients, TB infection must be ruled out through clinical diagnostic testing; 5. Full understanding of the study's purpose, procedures, risks, and benefits, with a voluntarily signed informed consent form (ICF); 6. Ability to cooperate with the collection of tongue swab and sputum samples to ensure specimen integrity and reliability.

Exclusion criteria

Exclusion criteria: 1. Patients with known immunodeficiency diseases; 2. Individuals unwilling or unable to provide informed consent; 3. Tongue swab specimens that the investigator deems necessary to exclude.

Design outcomes

Primary

MeasureTime frame
Accuracy;

Secondary

MeasureTime frame
Sensitivity;Specificity;

Countries

China

Contacts

Public ContactYu Pang

Beijing Chest Hospital Affiliated to Capital Medical University

pangyupound@163.com+86 138 1009 8209

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026