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Diagnostic Performance of a Novel Lipoarabinomannan.

NCT05036694 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2021-09-08

No results posted yet for this study

Summary

The Fujifilm SILVAMP TB LAM (FujiLAM; Fujifilm, Tokyo, Japan) is a novel (not commercialized) urine based point-of-care assay to diagnose TB in HIV-positive patients. A first study using urine frozen samples has reported a higher sensitivity of this test over the currently commercialised Alere Determine TB LAM Ag assay (AlereLAM).

Conditions

  • HIV Primary Infection

Interventions

DEVICE

FUJILAM KIT

Urine based test to detect LAM

Sponsors & Collaborators

  • Epicentre

    collaborator OTHER

  • Médecins Sans Frontières, Kenya

    lead OTHER

Principal Investigators

  • HELENA DR Coordinating Principal Investigator, PhD · MEDECIN SAN FRONTIERES

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2022-09-30
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05036694 on ClinicalTrials.gov