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Feasibility of a Lateral Flow Urine Lipoarabinomannan (LAM) Test for Diagnosis of Tuberculosis

NCT01525134 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2012-02-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the accuracy, diagnostic yield, operational performance, and time to diagnosis of a novel lateral-flow urine lipoarabinomannan (LAM) test in detecting tuberculosis in HIV-infected adults.

A secondary study objective is to determine the accuracy, efficiency, costs, and cost-effectiveness of various combinations of Tuberculosis (TB) diagnostic tests, including the novel Xpert MTB/Rif test.

Conditions

  • Tuberculosis
  • Tuberculosis, Pulmonary
  • Tuberculosis, Miliary

Interventions

DEVICE

Alere "Determine" lateral-flow urine lipoarabinomannan assay

lateral-flow (point-of-care) urine test to detect the lipoarabinomannan (LAM) component of the M. tuberculosis antigen in the urine of TB suspects, in vitro. Manufacturer: Alere

DEVICE

Alere "Clearview" ELISA urine LAM assay

ELISA-based urine test to detect the lipoarabinomannan component of the M. tuberculosis antigen in the urine of TB suspects, in vitro. Manufacturer: Alere.

Sponsors & Collaborators

  • Makerere University

    collaborator OTHER

  • Tuberculosis Clinical Diagnostics Research Consortium

    lead NETWORK

Principal Investigators

  • Susan Dorman, MD · Johns Hopkins University

  • Yukari Manabe, MD · Infectious Diseases Institute, Makerere University, Kampala, Uganda

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-02-29
Completion
2012-04-30

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

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 NCT01525134 on ClinicalTrials.gov