TB Triage+: Prospective, multicentre evaluation of the accuracy of CAD4TB and C-reactive protein assay as triage tests for the diagnosis of pulmonary tuberculosis in presumptive adult TB patients
Abstract
Tuberculosis (TB) is a poverty-related disease, which particularly affects vulnerable, hard-to-reach and underserved populations. Current intensified active case finding strategies for TB are not suitable to reach out to these population groups because of high operational costs and logistical challenges. A triage strategy in which an inexpensive, rapid screening test is performed first, and if positive, followed by a more expensive and time-consuming confirmatory assay, could substantially reduce diagnostic costs, improve early access to diagnosis and improve outcomes. This study works within a WHO consensus to develop new TB diagnostic tests that are: i) non-sputum based; ii) easy to use; iii) rapid; iv) accurate; v) affordable; and vi) usable with only minimal infrastructure and training needs. This study will assess CAD4TB (Delft Imaging System, NL), a digital chest x-ray analysis software, and a C-reactive protein assay (Alere Afinion, USA), which detects a cytokine induced acute phase protein in a community setting as triage tests for the diagnosis of TB.
