Prospective Multi-Site Validation of AI to Detect Tuberculosis and Chest X-Ray Abnormalities.

Abstract

Background: Using artificial intelligence (AI) to interpret chest X-rays (CXRs) could support accessible triage tests for active pulmonary tuberculosis (TB) in resource-constrained settings.

Methods: The performance of two cloud-based CXR AI systems - one to detect TB and the other to detect CXR abnormalities - in a population with a high TB and human immunodeficiency virus (HIV) burden was evaluated. We recruited 1978 adults who had TB symptoms, were close contacts of known TB patients, or were newly diagnosed with HIV at three clinical sites. The TB-detecting AI (TB AI) scores were converted to binary using two thresholds: a high-sensitivity threshold and an exploratory threshold designed to resemble radiologist performance. Ten radiologists reviewed images for signs of TB, blinded to the reference standard. Primary analysis measured AI detection noninferiority to radiologist performance. Secondary analysis evaluated AI detection as compared with the World Health Organization (WHO) targets (90% sensitivity, 70% specificity). Both used an absolute margin of 5%. The abnormality-detecting AI (abnormality AI) was evaluated for noninferiority to a high-sensitivity target suitable for triaging (90% sensitivity, 50% specificity).

Results: Of the 1910 patients analyzed, 1827 (96%) had conclusive TB status, of which 649 (36%) were HIV positive and 192 (11%) were TB positive. The TB AI's sensitivity and specificity were 87% and 70%, respectively, at the high-sensitivity threshold and 78% and 82%, respectively, at the balanced threshold. Radiologists' mean sensitivity was 76% and mean specificity was 82%. At the high-sensitivity threshold, the TB AI was noninferior to average radiologist sensitivity (P<0.001) but not to average radiologist specificity (P=0.99) and was higher than the WHO target for specificity but not sensitivity. At the balanced threshold, the TB AI was comparable to radiologists. The abnormality AI's sensitivity and specificity were 97% and 79%, respectively, with both meeting the prespecified targets.

Conclusions: The CXR TB AI was noninferior to radiologists for active pulmonary TB triaging in a population with a high TB and HIV burden. Neither the TB AI nor the radiologists met WHO recommendations for sensitivity in the study population. AI can also be used to detect other CXR abnormalities in the same population.