A real-world study of recombinant tuberculosis protein antigen ESAT6-CFP10 for screening for tuberculosis infection in high-risk populations

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2000036369

Enrollment

Unknown

Registered

2020-08-22

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-09-07

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

Conditions

Latent tuberculosis infection

Interventions

Gold Standard:serum IGRA test

Index test:recombinant&#32

tuberculosis&#32

protein&#32

antigen&#32

ESAT6-CFP10

Eligibility

Sex/Gender

All

Age

0.5 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. aged 6 months to 80 years old male or female; 2. Voluntarily accept serum IGRA test; 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

Measure	Time frame
accuracy;Kappa;	—

Secondary

Measure	Time frame
safety;	—

Countries

China

Contacts

Public ContactXuhui Liu

Shanghai Public Health Clinical Center

liuxuhui@shphc.org.cn+86 021-37990333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026