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
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 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.


Options:
A: 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
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:

1. Community participant willing to complete community-based symptom screening, urine testing and/or undergo TB diagnostic tests at the local TB clinic.
2. Provision of informed consent.
3. HIV-negative adults (older than 18 years) with 1 or more of the following:

   * cough ≥ 2 weeks
   * loss of weight
   * persistent fever ≥ 2 weeks and/or
   * a single recorded temp \> 38°C
   * night sweats
   * generalized fatigue
   * hemoptysis or
   * chest pain
4. Any HIV+ve adult (older than 18 years).

Exclusion Criteria:

1. Inability to provide informed consent (e.g. mentally impaired).
2. Patients self-presenting to the TB clinics.
D: Inclusion Criteria:

* Aged ≤ 12 years old (reported)
* HIV-1 positive (for example, two rapid HIV-1 antibody tests for children \>18 months and not breastfeeding, or one HIV-1 DNA/RNA test for children ≤18 months or who are breastfeeding)
* Not currently receiving antiretroviral therapy (history of pMTCT does not affect eligibility)
* Eligible to receive ART, according to current WHO guidelines
* Caregiver plans to reside in study catchment area for at least 6 months (reported)
* Caregiver provides sufficient locator information

Exclusion Criteria:

* Suspected meningitis, any other central nervous system infection, or encephalitis

Answer: B