Digital chest radiography with CAD shows variable sensitivity for asymptomatic tuberculosis in South African adults
This cohort study included 1353 adults aged 18 years or older in a community-based screening cohort and a facility-based triage cohort in South Africa. The intervention involved digital chest radiography (dCXR) read by blinded human readers and qXR CAD using a 0.5 threshold from Qure.AI, India. The comparator was symptomatic tuberculosis in the triage cohort. Outcomes measured included sensitivity and specificity for asymptomatic and symptomatic tuberculosis.
In the screening cohort, 48 cases (5.4%) were microbiologically confirmed tuberculosis, 9 cases (19%) were symptomatic tuberculosis, and 39 cases (81%) were asymptomatic tuberculosis. In the triage cohort, 116 cases (24.8%) were microbiologically confirmed tuberculosis. Human reader sensitivity for asymptomatic tuberculosis was 56.4% with a 95% confidence interval of -2.9 to -29.1. Human reader sensitivity for symptomatic tuberculosis was 72.4%.
Specificity for asymptomatic tuberculosis was 94.1% with human readers and 89.3% with qXR CAD. Specificity for symptomatic tuberculosis was 81.2% with human readers and 73.5% with qXR CAD. The study did not report adverse events, serious adverse events, discontinuations, or tolerability data. A key limitation is that neither human reader nor qXR CAD evaluation met WHO targets for a tuberculosis screening test, which require 90% sensitivity and 80% specificity.
The World Health Organization recommends digital chest radiography with computer-aided detection for tuberculosis screening of individuals older than 15 years of age. This study suggests that current dCXR and CAD performance in this setting may not fully align with those global screening targets.