Evaluation of QFT TB Gold Plus for Mycobacterium tuberculosis infection

Evaluation of QFT TB Gold Plus for Mycobacterium tuberculosis infection - Evaluation of QFT Plus

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000035253

Enrollment

190

Registered

2018-12-14

Start date

2017-11-30

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

active tuberculosis patients, LTBI patients, previous tuberculosis patients, healthy donors

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Active tuberculosis patients 1) Culture positive results. 2) Positive result of smear or nucleic acid amplification method in case of no culture result when the patients is enrolled. LTBI patients 1) No symptoms, physical findings and laboratory results consistent with tuberculosis. 2) Positive results for QFT-GIT. 3) No medical history of tuberculosis. 4) Negative result of smear and culture test for tuberculosis. Previous tuberculosis patients 1) No symptoms, physical findings and laboratory results consistent with tuberculosis. 2) Patients had history of tuberculosis. 3) Negative result of smear and culture test for tuberculosis. Healthy donor 1) No symptoms, physical findings and laboratory results consistent with tuberculosis. 2) Negative results for QFT-GIT. 3) No medical history of tuberculosis. 4) Negative result of smear and culture test for tuberculosis.

Exclusion criteria

Exclusion criteria: All subjects 1. patients aged under 18 years old. 2. treatment tuberculosis including fluoroquinolone for longer than 2 weeks. 3. Patients for whom the investigator decided not suitable for participation in this study. Active tuberculosis patients A negative result on culture test. LTBI patients Patients had history of tuberculosis. Healthy donor Subjects had history of tuberculosis. Subjects had history of contact to active tuberculosis patients.

Design outcomes

Primary

Measure	Time frame
sensitivity and specificity of QFT-Plus for diagnosing active tuberculosis patients	—

Secondary

Measure	Time frame
Sensitivity and specificity of QFT-Plus for immunocompromised active tuberculosis patients. Comparison of cytokine levels among supernatants of antigens in QFT-Plus and QFT-GIT. Monitoring QFT-Plus during treatment or follow up for active tuberculosis and LTBI patients. Evaluation of QFT-plus for previous tuberculosis patients. Discrimination between active tuberculosis and LTBI patient using cytokines in supernatants of QFT-Plus and QFT-GIT.	—

Measure

Time frame

Sensitivity and specificity of QFT-Plus for immunocompromised active tuberculosis patients. Comparison of cytokine levels among supernatants of antigens in QFT-Plus and QFT-GIT. Monitoring QFT-Plus during treatment or follow up for active tuberculosis and LTBI patients. Evaluation of QFT-plus for previous tuberculosis patients. Discrimination between active tuberculosis and LTBI patient using cytokines in supernatants of QFT-Plus and QFT-GIT.

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Countries

Japan

Contacts

Public ContactMaho Suzukawa

National Hospital Organization Tokyo National Hospital Clinical Research Center

fueta-tky@umin.ac.jp042-491-2111

Outcome results