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:

1. Any ventilated patients over 18 years of age with suspected TB (suggestive pulmonary infiltrates, a history of constitutional symptoms preceding the ICU admission, or patients known or suspected to be infected with the human immunodeficiency virus (HIV)).

Exclusion criteria:

1. Patients known to have active TB or to already be on antituberculous medication.
B: Inclusion Criteria:

* Individuals must meet all of the following inclusion criteria in order to be eligible to participate:

  * Age ≥ 19 years (age of majority) if enrolled in South Korea; age ≥ 18 years (age of majority) if enrolled in China
  * Provision of informed consent
  * Clinical signs and/or symptoms suggestive of pulmonary tuberculosis
  * Meets one of the following criteria:

A. Suspected or confirmed new pulmonary tuberculosis case who has received anti-tuberculosis drugs for less than 3 (three) days (target enrollment for Group A is approximately 50 participants).

B. Confirmed pulmonary tuberculosis with documented rifampin resistance, who has received anti-tuberculosis drugs for 31 days or less C. History of prior tuberculosis PLUS ongoing signs and/or symptoms of pulmonary tuberculosis PLUS suspected drug resistance

Exclusion Criteria:

* Inability to provide a sputum specimen
C: 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.
D: 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.

Answer: D