FujiLAM Prospective Evaluation Trial

Summary

This is a prospective, multicentre cohort study in which the accuracy and the diagnostic yield of the FujiLAM test will be assessed using a microbiological reference standard, an extended microbiological reference standard and a composite reference standard among inpatient and outpatient people living with HIV (PLHIV).

Conditions

• Diagnosis of Tuberculosis in People Living With HIV

Interventions

DEVICE

Fujifilm SILVAMP TB LAM

Fujifilm SILVAMP TB LAM detects the presence of lipoarabinomannan (LAM) in urine with a visually read lateral flow test that uses silver amplification.

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia

  collaborator OTHER

• Infectious Diseases Institute, Uganda

  collaborator OTHER

• Malawi-Liverpool-Wellcome Trust Clinical Research Programme

  collaborator OTHER

• Swiss Tropical & Public Health Institute

  collaborator OTHER

• Ifakara Health Institute

  collaborator OTHER

• University of Cape Town

  collaborator OTHER

• Viet Tiep Hospital

  collaborator OTHER

• National Tuberculosis Control Programme

  collaborator UNKNOWN

• Fujifilm

  collaborator INDUSTRY

• Omega Diagnostics

  collaborator UNKNOWN

• Tuberculosis and Lung Disease Hospital in Hai Phong

  collaborator UNKNOWN

• The HIV Netherlands Australia Thailand Research Collaboration

  collaborator OTHER

• Foundation for Innovative New Diagnostics, Switzerland

  lead OTHER

Principal Investigators

• Morten Ruhwald, MD · FIND Head of TB programme

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-13

Primary Completion

2021-12-31

Completion

2021-12-31

Countries

• Malawi
• South Africa
• Tanzania
• Thailand
• Uganda
• Vietnam
• Zambia

Study Locations