Start4All - Start Taking Action for TB Diagnosis (DARE-TB)

Trial design

Treatments tested in this trial

• Near point of care (NPOC) NAATs

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  * Near point of care instrument that can test tongue swabs and sputum swabs\[6\]. * Rapid molecular detection system for detecting infectious diseases included TB, able to provide accurate test results that are comparable to top laboratory PCR tests, while it is easier to sue and move around and only takes 15 to 35 minutes to conclude the result. * Sample: Tongue swab or sputum swab (when sputum can be produced). * Processed directly on the near point-of-care device. * Results will be automatically generated by the device and recorded in the case report form (CRF).

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• Low-complexity nucleic acid amplification tests (LC-NAATs)

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  * Semi-quantitative, nested real-time polymerase chain reaction (PCR) diagnostic test for the detection of Mycobacterium tuberculosis (MTB) complex DNA in unprocessed sputum samples\[9, 10\]. It can also detect rifampicin-resistance associated mutations in MTB. Results are automatically displayed on the screen of the system in less than 80 minutes. * Sample: Performed on sputum specimens where sputum can be produced. * Results are available within 1-2 days depending on site capacity. Reported back to participants at the Day 2 visit (individual test result)

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• LC-NAAT using pooled testing

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Platform available at the health facility will be used to perform pooled testing (4, 8, 16 or 32 modules). Sample/Procedure: Pooled testing involves combining equal volumes from multiple individuals' samples and testing them together using a single test\[10\]. Pools will be created using remaining samples from 2-4 participants who have screened positive and were able to produce a sputum, guided by CAD CXR-AI thresholds\[11\]. To the possible extend, pools will be suggested by CAD band score: 0.3 ≤ CAD \< 0.8 pooled together. No pooled testing is required with CAD ≥ 0.8.

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• Computer-Aided Detection (CAD) Chest X-ray (CXR-AI)

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Computer-aided detection (CAD) software for chest X-rays is designed to support rapid, automated screening for tuberculosis and other thoracic abnormalities. Operating on mobile or computer platforms, these tools can analyse chest X-rays in less than a minute, distinguishing normal from abnormal scans and highlighting findings in the lungs, pleura, mediastinum, bones, diaphragm, and heart. In addition to detecting disease, some systems can assist clinicians with tasks such as verifying device placement and measuring distances from anatomical landmarks.

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• Culture (reference standard)

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  The Mycobacterial Culture (solid or liquid, depending on country platform availability) is the gold-standard diagnostic test for tuberculosis. Culture detects viable Mycobacterium tuberculosis (MTB) organisms by growing them on selective media, allowing for confirmation of disease and, where relevant, downstream drug susceptibility testing (DST). Sample: Performed on sputum specimens where sputum can be produced. Turnaround time: Results are typically available within 2-8 weeks depending on the culture method (solid vs liquid) and laboratory capacity.

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• Sputum smear microscopy

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Sputum smear microscopy (Ziehl-Neelsen or fluorescent staining, depending on laboratory platform availability) is a conventional diagnostic method that detects Mycobacterium tuberculosis (MTB) through visualisation of acid-fast bacilli (AFB) under a microscope. While widely used, its sensitivity is limited, particularly in individuals with paucibacillary disease or those unable to produce quality sputum. Sample: Performed on sputum specimens where sputum can be produced. Turnaround time: As microscopy will be performed at referral laboratories (where culture is also conducted), results are typically available within several days to 1-2 weeks, depending on sample transport and laboratory processing schedules. Results are reported semi-quantitatively (Negative, Scanty, 1+, 2+, 3+) following WHO and national TB programme grading standards.

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