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Feasibility of a Lateral Flow Urine LAM Test for Diagnosis of Tuberculosis in South Africa

NCT01693224 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2012-09-26

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 LAM test in detecting tuberculosis in HIV-infected adults.

A secondary study objective is to evaluate the accuracy and diagnostic yield of the Cepheid Xpert MTB/Rif test in detecting tuberculosis in the blood of HIV-infected adults.

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.

DEVICE

Cepheid Xpert MTB/Rif assay

Sponsors & Collaborators

  • University of Cape Town

    collaborator OTHER

  • Tuberculosis Clinical Diagnostics Research Consortium

    lead NETWORK

Principal Investigators

  • Susan Dorman, MD · Johns Hopkins University

  • Mark Nicol, MBChB, PhD · University of Cape Town, Faculty of Health Sciences, Dept. of Medical Microbiology, Cape Town, South Africa

  • Mischka Moodley, MBChB, DTM&H, FCPath(Micro)SA · University of Cape Town, Faculty of Health Sciences, Dept. of Medical Microbiology, Cape Town, South Africa

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • South Africa

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 NCT01693224 on ClinicalTrials.gov