Evaluation of the effectiveness of FUJIFILM SILVAMP TB LAM for the diagnosis of patients with tuberculosis

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100052490

Enrollment

Unknown

Registered

2021-10-29

Start date

2021-11-01

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Tuberculosis

Interventions

Gold Standard:liquid cultures and GeneXpert MTB/RIF

Index test:FUJIFILM&#32

SILVAMP&#32

TB&#32

LAM

Eligibility

Sex/Gender

All

Age

15 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients between the ages of 15 and 70 who visit the CDC's tuberculosis prevention and control clinic; 2. Diagnosed patient group: Seeing a doctor at the TB clinic of the Centers for Disease Control and Prevention, and laboratory tests are positive for liquid culture and/or GeneXpert MTB/RIF; 3. Control group: patients who were treated at the CDC's tuberculosis clinic but were excluded from tuberculosis.

Exclusion criteria

Exclusion criteria: Saliva samples; contaminated sputum or urine samples, cloudy urine samples; samples with insufficient sample volume to complete the test; patients who cannot produce both sputum and urine.

Design outcomes

Primary

Measure	Time frame
Diagnostic efficacy of FUJIFILM SILVAMP TB LAM;	—

Countries

China

Contacts

Public ContactGao Qian

School of Basic Medical Sciences, Fudan University

qiangao@fudan.edu.cn+86 13671645425

Outcome results

None listed

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