Diagnostic accuracy of a commercial AI digital stethoscope for diagnosis of TB

Cox H.; Rani Y.; Nakiyingi L.; Francia K.A.; Xie Y.; Hoang C.; Hapeela N.; Romero G.P.; Nasinghe E.; Van Hung N.; Kim S.; Penn-Nicholson A.; Dorman S.E. · IJTLD Open (2025) · DOI: 10.5588/ijtldopen.25.0360

Resumen

BACKGROUND: Improved TB screening requires noninvasive, low-cost, and rapid diagnostics. Digital stethoscopes utilising machine-learning approaches to analyse respiratory sounds have potential. METHODS: We assessed accuracy of a commercial digital stethoscope for TB diagnosis among TB symptomatic participants. The microbiological reference standard (MRS) was sputum TB-positive on either liquid culture, solid culture, or Xpert MTB/RIF Ultra. Adults were enrolled from South Africa, Uganda, Vietnam, and Peru, with predefined sampling of 60 MRS-positive and 180 MRS-negative participants over two stages. Respiratory sounds from six auscultation positions on the participant’s torso were analysed. The manufacturer (blinded to MRS status) provided participant scores and a test-positivity cut-off. RESULTS: Among 240 participants, 135 (56%) were female, 62 (26%) living with HIV, 35 (15%) current smokers, and 31 (13%) previously treated for TB. Estimates of sensitivity and specificity, adjusted for country-stratified sampling, were 77% (95% confidence interval [CI]: 65–85) and 50% (95% CI: 43–57), respectively. Sensitivity was lower among people living with HIV and those with sputum smear–negative TB and varied by country. Testing took 5 min per participant (median, interquartile range 4–6). CONCLUSION: These early data suggest that further refinement of this test is warranted. The device is simple to use, is inexpensive, and can be used offline.

Instituciones: Universidad Peruana Cayetano Heredia