<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01693224</url>
  </required_header>
  <id_info>
    <org_study_id>DMID 10-0051</org_study_id>
    <secondary_id>NA_00043138</secondary_id>
    <nct_id>NCT01693224</nct_id>
  </id_info>
  <brief_title>Feasibility of a Lateral Flow Urine LAM Test for Diagnosis of Tuberculosis in South Africa</brief_title>
  <official_title>Feasibility of Using the Inverness Lateral Flow Urine LAM Test for Diagnosis of Tuberculosis in HIV-Positive TB Suspects in Cape Town, South Africa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tuberculosis Clinical Diagnostics Research Consortium</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Cape Town</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tuberculosis Clinical Diagnostics Research Consortium</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the accuracy, diagnostic yield, operational&#xD;
      performance, and time to diagnosis of a novel lateral-flow urine LAM test in detecting&#xD;
      tuberculosis in HIV-infected adults.&#xD;
&#xD;
      A secondary study objective is to evaluate the accuracy and diagnostic yield of the Cepheid&#xD;
      Xpert MTB/Rif test in detecting tuberculosis in the blood of HIV-infected adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Tuberculosis (TB) incidence and mortality have increased dramatically as a result&#xD;
      of the HIV epidemic. In parts of sub-Saharan Africa, TB is the leading cause of death among&#xD;
      HIV-infected patients and approximately 50% of TB patients are HIV co-infected. Early&#xD;
      treatment of TB is hindered by the lack of rapid, accurate diagnostic modalities that can be&#xD;
      applied in resource-constrained settings. Mycobacterial culture is the laboratory standard&#xD;
      for diagnosis of active TB, but it is costly, requires access to specialized laboratories,&#xD;
      and takes weeks to provide results. Sputum smear microscopy detects less than half of&#xD;
      HIV-infected TB cases in many settings. The Global Plan to Stop TB has prioritized the&#xD;
      development of simple, accurate, inexpensive tests for TB case detection in HIV-positive&#xD;
      individuals.&#xD;
&#xD;
      LAM: As a strategy for rapid TB diagnosis, the detection of Mycobacterium tuberculosis&#xD;
      antigens has been explored over several decades. Lipoarabinomannan (LAM), a glycolipid&#xD;
      component of the outer cell wall of mycobacteria, is an attractive diagnostic target for&#xD;
      several reasons: it is heat-stable; cleared by the kidney; detectable in urine; and as a&#xD;
      bacterial product, has the theoretical potential to discriminate active TB from latent TB&#xD;
      infection independent of human immune responses. A urine test could facilitate TB diagnosis&#xD;
      in patients in whom sputum is uninformative or not obtainable, and lacks the&#xD;
      infection-control risks associated with sputum production or blood collection. Urine LAM&#xD;
      detection may be amenable to simple, rapid, inexpensive point-of-care platforms.&#xD;
&#xD;
      This is a prospective study to evaluate the accuracy, diagnostic yield, operational&#xD;
      performance, and time to diagnosis of a novel lateral-flow urine LAM test in detecting&#xD;
      tuberculosis in HIV-infected adults. HIV-positive adults suspected to have TB will be&#xD;
      enrolled after providing informed consent. Urine will be obtained for testing using the novel&#xD;
      lateral flow urine LAM assay and an existing ELISA-based urine LAM assay. Conventional&#xD;
      microbiological tests for TB and chest x-rays will also be performed. These tests will be&#xD;
      performed on all participants enrolled (target sample size = 500).&#xD;
&#xD;
      A secondary study objective is to determine the accuracy and diagnostic yield of the Cepheid&#xD;
      Xpert MTB/Rif test in detecting tuberculosis in the blood of HIV-infected adults (the same&#xD;
      set of participants on whom the LAM testing is done; approximate sample size = 500).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>April 2011</start_date>
  <completion_date type="Anticipated">February 2013</completion_date>
  <primary_completion_date type="Anticipated">February 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity of the lateral-flow urine LAM assay (LF-LAM)</measure>
    <time_frame>One year</time_frame>
    <description>Conventional TB tests (mycobacterial blood &amp; sputum culture) will be the reference standard used to calculate sensitivity of the LF-LAM test&#xD;
Sensitivity is defined as TP/(TP+FN), or the number of true positives over (the number of true positives + the number of false negatives)&#xD;
&quot;true positive&quot; = a positive LF-LAM result in a patient also having ≥1 culture positive for M. tuberculosis&#xD;
&quot;false negative&quot; = a negative LF-LAM result in a patient also having ≥1 culture positive for M. tuberculosis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Failure rate of the lateral-flow urine LAM assay</measure>
    <time_frame>One year</time_frame>
    <description>Failure rate expressed as the proportion of lateral flow urine LAM tests that require repeating due to an unevaluable initial result</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inter-reader variability of the lateral-flow urine LAM assay</measure>
    <time_frame>One year</time_frame>
    <description>Expressed as the percent agreement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specificity of the lateral-flow urine LAM assay (LF-LAM)</measure>
    <time_frame>One year</time_frame>
    <description>Conventional TB tests (blood &amp; sputum culture) will be the reference standard used to calculate specificity (Sp) of the LF-LAM&#xD;
Sp=TN/(TN+FP), or #true negatives / (#true negatives + #false positives)&#xD;
&quot;true negative&quot; = negative LF-LAM in &quot;Not TB&quot; patient&#xD;
&quot;false positive&quot; = positive LF-LAM in &quot;Not TB&quot; patient&#xD;
&quot;Not TB&quot; = meets all criteria below&#xD;
no sputum/blood culture positive for MTB&#xD;
no smear microscopy positive for acid-fast bacilli&#xD;
no granulomas/caseous necrosis on histopathology&#xD;
no clinical response to TB treatment&#xD;
a plausible alternative diagnosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of the ELISA-based urine LAM test</measure>
    <time_frame>One year</time_frame>
    <description>Conventional TB tests (mycobacterial blood &amp; sputum culture) will be the reference standard used to calculate sensitivity of the ELISA LAM test&#xD;
Sensitivity is defined as TP/(TP+FN), or the number of true positives over (the number of true positives + the number of false negatives)&#xD;
&quot;true positive&quot; = a positive ELISA LAM result in a patient also having ≥1 culture positive for M. tuberculosis&#xD;
&quot;false negative&quot; = a negative ELISA LAM result in a patient also having ≥1 culture positive for M. tuberculosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic yield (expressed as number of TB cases detected) of various diagnostic strategies (see description)</measure>
    <time_frame>One year</time_frame>
    <description>Diagnostic yield will be measured for strategies including a) lateral flow urine LAM testing plus sputum smear microscopy; b) ELISA urine LAM testing plus sputum smear microscopy; c) sputum smear microscopy plus sputum culture; d) sputum culture plus mycobacterial blood culture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to diagnosis (expressed in days) of various diagnostic strategies (see description)</measure>
    <time_frame>One year</time_frame>
    <description>Time to diagnosis will be measured for strategies including a) lateral flow urine LAM testing plus sputum smear microscopy; b) ELISA urine LAM testing plus sputum smear microscopy; c) sputum smear microscopy plus sputum culture; d) sputum culture plus mycobacterial blood culture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy, efficiency, costs, and cost-effectiveness of various combinations of TB diagnostic tests</measure>
    <time_frame>One year</time_frame>
    <description>TB diagnostic tests to be included in this analysis: sputum smear microscopy, sputum culture, mycobacterial blood culture, chest X-ray, lateral-flow urine LAM testing, ELISA urine LAM testing, and Xpert MTB/Rif.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of lateral-flow urine LAM test operators</measure>
    <time_frame>One year</time_frame>
    <description>Based on questionnaire assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity (Sp) of the ELISA-based urine LAM test</measure>
    <time_frame>One year</time_frame>
    <description>Conventional TB tests (blood &amp; sputum culture) will be the reference standard used to calculate Sp of ELISA LAM&#xD;
Sp=TN/(TN+FP), or #true negatives / (#true negatives + #false positives)&#xD;
&quot;true negative&quot; = negative ELISA LAM in &quot;Not TB&quot; patient&#xD;
&quot;false positive&quot; = positive ELISA LAM in &quot;Not TB&quot; patient&#xD;
&quot;Not TB&quot; = meets all criteria below&#xD;
no sputum/blood culture positive for MTB&#xD;
no smear microscopy positive for acid-fast bacilli&#xD;
no granulomas/caseous necrosis on histopathology&#xD;
no clinical response to TB treatment&#xD;
a plausible alternative diagnosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of the Xpert MTB/Rif test to detect MTB in blood</measure>
    <time_frame>One year</time_frame>
    <description>Conventional mycobacterial blood culture will be the reference standard used to calculate sensitivity of Xpert MTB/Rif in blood&#xD;
Sensitivity is defined as TP/(TP+FN), or the number of true positives over (the number of true positives + the number of false negatives)&#xD;
&quot;true positive&quot; = a positive Xpert MTB/Rif result in a patient also having ≥1 mycobacterial blood culture positive for M. tuberculosis&#xD;
&quot;false negative&quot; = a negative Xpert MTB/Rif result in a patient also having ≥1 mycobacterial blood culture positive for M. tuberculosis</description>
  </secondary_outcome>
  <enrollment type="Actual">512</enrollment>
  <condition>Tuberculosis</condition>
  <condition>Tuberculosis, Pulmonary</condition>
  <condition>Tuberculosis, Miliary</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Alere &quot;Determine&quot; lateral-flow urine lipoarabinomannan assay</intervention_name>
    <description>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.&#xD;
Manufacturer: Alere</description>
    <other_name>Determine lateral-flow urine LAM TB test</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Alere &quot;Clearview&quot; ELISA urine LAM assay</intervention_name>
    <description>ELISA-based urine test to detect the lipoarabinomannan component of the M. tuberculosis antigen in the urine of TB suspects, in vitro.&#xD;
Manufacturer: Alere.</description>
    <other_name>Clearview ELISA urine LAM TB test</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cepheid Xpert MTB/Rif assay</intervention_name>
    <other_name>Cepheid Xpert MTB/Rif test</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (Individuals must meet all of the following inclusion criteria in order&#xD;
        to be eligible to participate):&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Suspected active tuberculosis&#xD;
&#xD;
          -  Willingness and ability to comply with study procedures&#xD;
&#xD;
          -  Any one or more of the following:&#xD;
&#xD;
               -  Current cough&#xD;
&#xD;
               -  Fever at any time within the preceding 4 weeks&#xD;
&#xD;
               -  Night sweats at any time within the preceding 4 weeks&#xD;
&#xD;
               -  Weight loss within the preceding 4 weeks&#xD;
&#xD;
          -  HIV-positive based on any one or more of the following:&#xD;
&#xD;
               -  written results of a positive HIV antibody test, and/or&#xD;
&#xD;
               -  written results of a positive HIV viral load, and/or&#xD;
&#xD;
               -  documentation in the medical record of positive HIV status by a treating&#xD;
                  clinician.&#xD;
&#xD;
        Exclusion Criteria (Any subjects meeting any of the following exclusion criteria at&#xD;
        baseline will be excluded from study participation):&#xD;
&#xD;
          -  Multidrug tuberculosis treatment for greater than two days within the previous 60 days&#xD;
&#xD;
          -  Unwillingness or inability to provide a urine sample&#xD;
&#xD;
          -  Known chronic pulmonary condition, e.g. asthma, chronic obstructive pulmonary disease,&#xD;
             emphysema&#xD;
&#xD;
          -  Respiratory distress, defined as respiratory rate of &gt;30 or oxygen saturation &lt;90%&#xD;
&#xD;
          -  Any specific condition that in the judgment of the investigator precludes&#xD;
             participation because it could affect a subject's safety.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Dorman, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark Nicol, MBChB, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cape Town, Faculty of Health Sciences, Dept. of Medical Microbiology, Cape Town, South Africa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mischka Moodley, MBChB, DTM&amp;H, FCPath(Micro)SA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cape Town, Faculty of Health Sciences, Dept. of Medical Microbiology, Cape Town, South Africa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>G.F. Jooste Hospital</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Town Two Clinic</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>September 23, 2012</last_update_submitted>
  <last_update_submitted_qc>September 23, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tests, Diagnostic</keyword>
  <keyword>Mycobacterium tuberculosis</keyword>
  <keyword>Mycobacterium tuberculosis antigens</keyword>
  <keyword>TB</keyword>
  <keyword>Tuberculosis</keyword>
  <keyword>Tuberculosis, Pulmonary</keyword>
  <keyword>Tuberculosis, Miliary</keyword>
  <keyword>Lipoarabinomannan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Tuberculosis, Pulmonary</mesh_term>
    <mesh_term>Tuberculosis, Miliary</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01693224
org study id: DMID 10-0051
secondary id: NA_00043138
nct id: NCT01693224
lead sponsor: 
collaborator: 
has dmc: No
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.
Background: Tuberculosis (TB) incidence and mortality have increased dramatically as a result
      of the HIV epidemic. In parts of sub-Saharan Africa, TB is the leading cause of death among
      HIV-infected patients and approximately 50% of TB patients are HIV co-infected. Early
      treatment of TB is hindered by the lack of rapid, accurate diagnostic modalities that can be
      applied in resource-constrained settings. Mycobacterial culture is the laboratory standard
      for diagnosis of active TB, but it is costly, requires access to specialized laboratories,
      and takes weeks to provide results. Sputum smear microscopy detects less than half of
      HIV-infected TB cases in many settings. The Global Plan to Stop TB has prioritized the
      development of simple, accurate, inexpensive tests for TB case detection in HIV-positive
      individuals.

      LAM: As a strategy for rapid TB diagnosis, the detection of Mycobacterium tuberculosis
      antigens has been explored over several decades. Lipoarabinomannan (LAM), a glycolipid
      component of the outer cell wall of mycobacteria, is an attractive diagnostic target for
      several reasons: it is heat-stable; cleared by the kidney; detectable in urine; and as a
      bacterial product, has the theoretical potential to discriminate active TB from latent TB
      infection independent of human immune responses. A urine test could facilitate TB diagnosis
      in patients in whom sputum is uninformative or not obtainable, and lacks the
      infection-control risks associated with sputum production or blood collection. Urine LAM
      detection may be amenable to simple, rapid, inexpensive point-of-care platforms.

      This is a prospective study 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. HIV-positive adults suspected to have TB will be
      enrolled after providing informed consent. Urine will be obtained for testing using the novel
      lateral flow urine LAM assay and an existing ELISA-based urine LAM assay. Conventional
      microbiological tests for TB and chest x-rays will also be performed. These tests will be
      performed on all participants enrolled (target sample size = 500).

      A secondary study objective is to determine the accuracy and diagnostic yield of the Cepheid
      Xpert MTB/Rif test in detecting tuberculosis in the blood of HIV-infected adults (the same
      set of participants on whom the LAM testing is done; approximate sample size = 500).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sensitivity of the lateral-flow urine LAM assay (LF-LAM)
time frame: One year
description: Conventional TB tests (mycobacterial blood & sputum culture) will be the reference standard used to calculate sensitivity of the LF-LAM test
Sensitivity is defined as TP/(TP+FN), or the number of true positives over (the number of true positives + the number of false negatives)
"true positive" = a positive LF-LAM result in a patient also having ≥1 culture positive for M. tuberculosis
"false negative" = a negative LF-LAM result in a patient also having ≥1 culture positive for M. tuberculosis
measure: Failure rate of the lateral-flow urine LAM assay
time frame: One year
description: Failure rate expressed as the proportion of lateral flow urine LAM tests that require repeating due to an unevaluable initial result
measure: Inter-reader variability of the lateral-flow urine LAM assay
time frame: One year
description: Expressed as the percent agreement
measure: Specificity of the lateral-flow urine LAM assay (LF-LAM)
time frame: One year
description: Conventional TB tests (blood & sputum culture) will be the reference standard used to calculate specificity (Sp) of the LF-LAM
Sp=TN/(TN+FP), or #true negatives / (#true negatives + #false positives)
"true negative" = negative LF-LAM in "Not TB" patient
"false positive" = positive LF-LAM in "Not TB" patient
"Not TB" = meets all criteria below
no sputum/blood culture positive for MTB
no smear microscopy positive for acid-fast bacilli
no granulomas/caseous necrosis on histopathology
no clinical response to TB treatment
a plausible alternative diagnosis
measure: Sensitivity of the ELISA-based urine LAM test
time frame: One year
description: Conventional TB tests (mycobacterial blood & sputum culture) will be the reference standard used to calculate sensitivity of the ELISA LAM test
Sensitivity is defined as TP/(TP+FN), or the number of true positives over (the number of true positives + the number of false negatives)
"true positive" = a positive ELISA LAM result in a patient also having ≥1 culture positive for M. tuberculosis
"false negative" = a negative ELISA LAM result in a patient also having ≥1 culture positive for M. tuberculosis
measure: Diagnostic yield (expressed as number of TB cases detected) of various diagnostic strategies (see description)
time frame: One year
description: Diagnostic yield will be measured for strategies including a) lateral flow urine LAM testing plus sputum smear microscopy; b) ELISA urine LAM testing plus sputum smear microscopy; c) sputum smear microscopy plus sputum culture; d) sputum culture plus mycobacterial blood culture.
measure: Time to diagnosis (expressed in days) of various diagnostic strategies (see description)
time frame: One year
description: Time to diagnosis will be measured for strategies including a) lateral flow urine LAM testing plus sputum smear microscopy; b) ELISA urine LAM testing plus sputum smear microscopy; c) sputum smear microscopy plus sputum culture; d) sputum culture plus mycobacterial blood culture.
measure: Accuracy, efficiency, costs, and cost-effectiveness of various combinations of TB diagnostic tests
time frame: One year
description: TB diagnostic tests to be included in this analysis: sputum smear microscopy, sputum culture, mycobacterial blood culture, chest X-ray, lateral-flow urine LAM testing, ELISA urine LAM testing, and Xpert MTB/Rif.
measure: Satisfaction of lateral-flow urine LAM test operators
time frame: One year
description: Based on questionnaire assessment
measure: Specificity (Sp) of the ELISA-based urine LAM test
time frame: One year
description: Conventional TB tests (blood & sputum culture) will be the reference standard used to calculate Sp of ELISA LAM
Sp=TN/(TN+FP), or #true negatives / (#true negatives + #false positives)
"true negative" = negative ELISA LAM in "Not TB" patient
"false positive" = positive ELISA LAM in "Not TB" patient
"Not TB" = meets all criteria below
no sputum/blood culture positive for MTB
no smear microscopy positive for acid-fast bacilli
no granulomas/caseous necrosis on histopathology
no clinical response to TB treatment
a plausible alternative diagnosis
measure: Sensitivity of the Xpert MTB/Rif test to detect MTB in blood
time frame: One year
description: Conventional mycobacterial blood culture will be the reference standard used to calculate sensitivity of Xpert MTB/Rif in blood
Sensitivity is defined as TP/(TP+FN), or the number of true positives over (the number of true positives + the number of false negatives)
"true positive" = a positive Xpert MTB/Rif result in a patient also having ≥1 mycobacterial blood culture positive for M. tuberculosis
"false negative" = a negative Xpert MTB/Rif result in a patient also having ≥1 mycobacterial blood culture positive for M. tuberculosis
intervention type: Device
intervention name: Alere "Determine" lateral-flow urine lipoarabinomannan assay
description: 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
other name: Determine lateral-flow urine LAM TB test
intervention type: Device
intervention name: Alere "Clearview" ELISA urine LAM assay
description: ELISA-based urine test to detect the lipoarabinomannan component of the M. tuberculosis antigen in the urine of TB suspects, in vitro.
Manufacturer: Alere.
other name: Clearview ELISA urine LAM TB test
intervention type: Device
intervention name: Cepheid Xpert MTB/Rif assay
other name: Cepheid Xpert MTB/Rif test
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susan Dorman, MD
role: Study Chair
affiliation: Johns Hopkins University
last name: Mark Nicol, MBChB, PhD
role: Principal Investigator
affiliation: University of Cape Town, Faculty of Health Sciences, Dept. of Medical Microbiology, Cape Town, South Africa
last name: Mischka Moodley, MBChB, DTM&H, FCPath(Micro)SA
role: Principal Investigator
affiliation: University of Cape Town, Faculty of Health Sciences, Dept. of Medical Microbiology, Cape Town, South Africa
facility: 
facility: 
country: South Africa
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Tuberculosis, Pulmonary
mesh term: Tuberculosis, Miliary