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Development, clinical evaluation and application of urine rapid diagnostic reagent for tuberculosis

Development, clinical evaluation and application of urine rapid diagnostic reagent for tuberculosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000037504
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-19

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

Conditions

tuberculosis

Interventions

Gold Standard: sputum tuberculomyces culture
Index test:A&#32
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LAM&#32
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urine

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-90 years old; 2. Willing to accept chest imaging and sputum tuberculosis culture detection; 3. Willing to provide medical history information; 4. Informed consent obtained.

Exclusion criteria

Exclusion criteria: 1. With a history of mental illness or cognitive dysfunction; 2. Pregnant or lactating women; 3. Receive live vaccines or biological agents within 4 weeks.

Design outcomes

Primary

MeasureTime frame
test accuracy;

Secondary

MeasureTime frame
Detection stability;

Countries

China

Contacts

Public ContactXiaoyong Fan

Shanghai Public Health Clinical Center

xyfan008@126.com+86 18916080562

Outcome results

None listed

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