Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective, Multicentre Trial to Assess the Diagnostic Accuracy of the Truenat Assays at Intended Settings of Use
Brief Summary: Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis will be interviewed for demographic and medical information, and then will be asked to provide 3-4 expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis and rifampin resistance.


Options:
A: Inclusion Criteria:

* Patients suspected of having pulmonary TB
* Cough ≥ 2 weeks
* At least one other TB clinical symptom

  * Fever
  * Unexplained weight loss
  * Loss of appetite
  * Hemoptysis
  * Shortness of breath
  * Chest pain
  * Night sweats
  * Fatigue
* Suggestive TB on chest x-ray based on pulmonologist or internist consultant of pulmonology opinion
* Age ≥ 18 years' old
* Willing to be treated or evaluated at study site
* Willing to have specimens stored for use in future studies
* Patient denies having TB treatment for more than 7 days in the last 1 month (30 days).

Exclusion Criteria:

Pregnancy or any serious condition includes, but not limited to, liver disease, chronic kidney disease, and psychiatric illness that might interfere with study compliance (based on the clinician judgment).
B: Inclusion Criteria:

* The patient is willing to provide specimens (urine, blood, stool, respiratory tract specimens and swabs)
* The patient is clinically suspected of having TB (Two WHO TB symptoms for HIV negative patients and one WHO TB symptom if HIV positive)

Exclusion Criteria:

* The patient is under the age of 18 years old
* The patient declines consent
* The patient has too few clinical symptoms for TB
C: Inclusion Criteria:

Case Detection Group:

* Age 18 years or above
* Clinical suspicion of pulmonary TB (including cough ≥2 week and at least 1 other symptom typical of TB);
* Willingness to provide 3-4 sputum specimens at enrolment;
* Willingness to have a trial follow-up visit approximately 2 months after enrolment;
* Provision of informed consent.

Drug Resistant TB Group:

In addition to the criteria of the Case Detection Group, participants should also meet the following conditions:

* Non-converting pulmonary TB cases (category I and category II failures)

Exclusion Criteria:

Case Detection Group:

* Receipt of any dose of TB treatment within 60 days prior to enrolment (even if within last two days only).

Drug Resistant TB Group:

* Receipt of any dose of MDR-TB treatment within 60 days prior to enrolment (even if within last two days only).
D: HIV-positive viral load monitoring patients

Inclusion Criteria:

* Informed consent obtained from patient
* Patient is more than 18 years old
* Patient is HIV positive
* Patient is receiving follow-up ART
* Patient is willing to provide blood specimens for study

Exclusion Criteria:

* Informed consent not obtained from patient
* Patient is less than 18 years old
* Patient is HIV negative or has unknown HIV status
* Patient is coming into clinic for first time ART
* Patient is not willing to provide blood specimens for study

TB patients

Inclusion Criteria:

* Informed consent obtained from patient
* Patient is more than 18 years old
* Patient is HIV positive
* Patient is coming into clinic for first ART visit
* Patient is willing to provide sputum and urine (blood is desirable, but not mandatory) specimens for study

Exclusion Criteria:

* Informed consent not obtained from patient
* Patient is less than 18 years old
* Patient is HIV negative or has unknown HIV status
* Patient is not coming into clinic for first time ART
* Patient has been on TB treatment within the last 60 days
* Patient is not willing to provide sputum and urine specimens for study

Answer: C