Please select the eligibility criteria that correspond to the clinical trial below.
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
Brief 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.


Options:
A: Inclusion Criteria (Individuals must meet all of the following inclusion criteria in order to be eligible to participate):

* Informed consent
* Suspected active tuberculosis
* Willingness and ability to comply with study procedures
* Any one or more of the following:

  * Current cough
  * Fever at any time within the preceding 4 weeks
  * Night sweats at any time within the preceding 4 weeks
  * Weight loss within the preceding 4 weeks
* HIV-positive based on any one or more of the following:

  * written results of a positive HIV antibody test, and/or
  * written results of a positive HIV viral load, and/or
  * documentation in the medical record of positive HIV status by a treating clinician.

Exclusion Criteria (Any subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation):

* Multidrug tuberculosis treatment for greater than two days within the previous 60 days
* Unwillingness or inability to provide a urine sample
* Known chronic pulmonary condition, e.g. asthma, chronic obstructive pulmonary disease, emphysema
* Respiratory distress, defined as respiratory rate of \>30 or oxygen saturation \<90%
* Any specific condition that in the judgment of the investigator precludes participation because it could affect a subject's safety.
B: Inclusion Criteria (Individuals must meet all of the following inclusion criteria in order to be eligible to participate):

* Informed consent
* Suspected active tuberculosis
* Willingness and ability to comply with study procedures
* Any one or more of the following:

  * Current cough
  * Fever at any time within the preceding 4 weeks
  * Night sweats at any time within the preceding 4 weeks
  * Weight loss within the preceding 4 weeks
* HIV-positive based on any one or more of the following:

  * written results of a positive HIV antibody test, and/or
  * written results of a positive HIV viral load, and/or
  * documentation in the medical record of positive HIV status by a treating clinician.

Exclusion Criteria (Any subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation):

* Multidrug tuberculosis treatment for greater than two days within the previous 60 days
* Unwillingness or inability to provide a urine sample
* Known chronic pulmonary condition, e.g. asthma, chronic obstructive pulmonary disease, emphysema
* Respiratory distress, defined as respiratory rate of \>30 or oxygen saturation \<90%
* Any specific condition that in the judgment of the investigator precludes participation because it could affect a subject's safety.
C: * INCLUSION CRITERIA:

For the new cases disease group (Cohort A):

1. Age greater than or equal to 20 years old;
2. Primary treatment (new TB subject by WHO definition) for tuberculosis without treatment interruption (greater than or equal to 60 days) and with at least 4 months of treatment remaining;
3. Clinical signs or symptoms suggestive of tuberculosis;
4. Sputum AFB smear-positivity or confirmed MTB using any molecular test

For previously treated disease group (Cohort B):

1. Age greater than or equal to 20 years old;
2. Treated for tuberculosis previously with more than 30 days of drug treatment and either:

   1. a treatment interruption of greater than or equal to 60 days (includes relapse and treatment after interruption), or
   2. who have experienced treatment failure or have chronic TB.
3. Clinical signs or symptoms suggestive of tuberculosis;
4. Sputum AFB smear-positivity or confirmed MTB using any molecular test

For healthy controls (Cohort C):

1. Age greater than or equal to 20 years old;
2. No previous diagnosis of TB as reported by the subject;

EXCLUSION CRITERIA:

For TB Subjects

1. Women who report themselves to be pregnant or possibly pregnant during the protocol introduction and consent process (pregnant women are not normally treated at NMTH).

For Healthy Volunteers:

1. Women who report themselves to be pregnant or those found to be pregnant by a urine Beta-HCG test during the protocol introduction and consent process.
2. Those having a chest X-ray suggestive of active tuberculosis.
D: Inclusion Criteria:

* HIV-infected (1x rapid HIV test positive)
* Considered TB suspect by attending doctor (must comprise at least 1 of the following: current fever or cough, drenching night sweats, self-reported LOW)
* Illness severity sufficient to warrant hospitalization
* ≥18 years old
* Provision of informed consent

Exclusion Criteria:

* HIV-uninfected
* Patients receiving any anti-TB medication in the 60 days prior to testing
* Unable to provide 30mls urine
* Inability to provide informed consent

Answer: A