Diagnostic accuracy of loop-mediated isothermal amplification (TB-LAMP) for tuberculosis in childre

Not Applicable

Recruiting

• Conditions: Clinically suspected tuberculosis(Presumptive tuberculosis); Tuberculosis in children; Tuberculosis diagnosis in children; Molecular diagnosis of tuberculosis; Loop- mediated isothermal amplification for detection of Mycobacterium tuberculosis(TB- LAMP)

• Registration Number: TCTR20200414003
• Lead Sponsor: Ratchadapisek Sompoch Endowment Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-14
• Study Completion: 2021-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Children age < 18-year-old with clinically suspected TB

Exclusion Criteria

Insufficient specimen for TB-LAMP

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall sensitivity & specificity of TB-LAMP for diagnosing tuberculosis in children within 7 days after specimen collection TB-LAMP method

Secondary Outcome Measures

Name	Time	Method
sensitivity & specificity of TB-LAMP in pulmonary TB within 7 days after specimen collection TB-LAMP method,sensitivity & specificity of TB-LAMP in extrapulmonary TB within 7 days after specimen collection TB-LAMP method,Sensitivity & specificity of TB-LAMP in smear positive and smear negative pulmonary tuberculosis within 7 days after specimen collection TB-LAMP method,Sensitivity & specificity of TB-LAMP compared with AFB, PCR for MTBC, Xpert MTB/RIF within 7 days after specimen collection TB-LAMP method