Start Taking Action For TB Diagnosis

Not yet recruitingOBSERVATIONAL
Enrollment

15,300

Participants

Timeline

Start Date

September 30, 2023

Primary Completion Date

October 31, 2024

Study Completion Date

October 31, 2026

Conditions
DiagnosisTuberculosis
Interventions
DIAGNOSTIC_TEST

Molecular Diagnostics

pooled sputum samples will be used at the site of sample collection on the EDGE platform using Xpert ULTRA cartridges

DIAGNOSTIC_TEST

Qualitative C-Reactive Protein (CRP)

CRP qualitative (POC) rapid tests are immunochromatographic based assays for qualitative or semiquantitative determination of CRP circulating in blood, serum or plasma at the Point of Care with a time to result in 5 minutes.

DIAGNOSTIC_TEST

Point of Care (POC) C-Reactive Protein (CRP): Quantitative CRP

CRP quantitative (POC) devices are platforms for quantitative determination (in mg/L) of C-reactive Protein (CRP) circulating in blood at the Point of Care with a time to result of 5 minutes. These are antibody-based assays that measure the antigen and antibody reactions between monoclonal antibodies to human CRP.

DIAGNOSTIC_TEST

Urine lateral flow tests

The assay combines a pair of high affinity monoclonal antibodies directed towards largely Mycobacterium tuberculosis-specific lipoarabinomannan epitopes and a silver-amplification step that increases the visibility of test and control lines. This enables the detection of urinary lipoarabinomannan concentrations that are approximately 30 times lower than that detected by a previous test called AlereLAM and improved analytical specificity compared with AlereLAM.

DIAGNOSTIC_TEST

Portable Chest X Ray Image Acquisition

Qure.ai (Qure.ai, New York, USA) is a computer aided detection (CAD) software for the automated screening of tuberculosis. Qure.ai is a mobile based interpretation software that screens chest X-Ray to detect TB in less than a minute. Qure.ai can distinguish abnormal scans from normal and detect abnormalities in the lungs, pleura, mediastinum, bones, diaphragm, and heart.

All Listed Sponsors
lead

Liverpool School of Tropical Medicine

OTHER

NCT05845112 - Start Taking Action For TB Diagnosis | Biotech Hunter | Biotech Hunter