Acoustic signal analysis has been employed in various medical devices. However, studies involving cough sound analysis to screen the potential Pulmonary Tuberculosis (PTB) suspects are very few. The main objective of this cross-sectional validation study was to develop and validate the Swaasa AI platform to screen and prioritize at risk patients for PTB based on the signature cough sound as well as symptomatic information provided by the subjects. The voluntary cough sound data was collected at Andhra Medical College-India. An Algorithm based on multimodal Convolutional Neural Network (CNN) architecture and tabular features was built and validated on a total of 567 subjects, comprising 278 positive and 289 negative PTB cases. The output from these two models was combined to detect the likely presence (positive cases) of PTB. In the clinical validation phase, the AI-model was found to be 86.82% accurate in detecting the likely presence of PTB with 90.36% sensitivity and 84.67% specificity. The pilot testing of Swaasa was conducted at a peripheral health care centre, RHC Simhachalam-India on 65 presumptive PTB cases. Out of which, 15 subjects truly turned out to be PTB positive with a Positive Predictive Value of 75%. The validation results obtained from Swaasa AI Platform are quite encouraging. This platform has the potential to fulfil the unmet need of a cost-effective PTB screening method. It works remotely, presents instantaneous results, and does not require a highly trained operator. Therefore, it could be implemented in various inaccessible, resource-poor parts of the world.

The authors have declared no competing interest.

CTRI/2021/09/036609

http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=60601&EncHid=&userName=Swaasa%20Artificial%20Intelligence%20Platform%20for%20detecting%20likely%20presence%20of%20Pulmonary%20Tuberculosis

This study is supported by the UK Government (British High Commission, New Delhi). This is a commissioned research report on commercial terms between C-CAMP and the UK Government (British High Commission, New Delhi).

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The methods were performed in accordance with relevant guidelines and regulations and approved by Andhra Medical college (AMC)- Institutional Ethics Committee (IEC).

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All data produced in the present study are available upon reasonable request to the authors