RAIsonance, a family of AI-powered technology solution companies, has announced the preliminary results of its AudibleHealth Dx clinical validation study.

The study evaluated AudibleHealth Dx Software as a Medical Device (SaMD) using Forced Cough Vocalization-Signal Data Signature (FCV-SDS) for the diagnosis of Covid-19.

The trial, conducted in the second quarter of 2022 in Florida, intended to validate the AudibleHealth Dx device’s efficacy from 514 participants with a prevalence of 12.8%.

RAIsonance said a request for an Emergency Use Authorization (EUA) will be submitted to the US Food and Drug Administration with the help of the study’s findings in the next weeks.

The study was a prospective, multi-site trial that compared the AudibleHealth Dx Covid-19 test to de novo-authorised RT-PCR Covid-19 test when using the AudibleHealth Dx SaMD to detect Covid-19 infections.

For the clinical validation research, the AudibleHealth Dx SaMD’s capacity to appropriately diagnose Covid-19 was compared to the BioFire RP2.1 Panel.

The results showed a Positive Percent Agreement (PPA) of 81% and a Negative Percent Agreement (NPA) of at least 80% when compared to the very sensitive reverse transcription-polymerase chain reaction (RT-PCR) test.

In the study, males and females aged 18 and older who underwent elective, outpatient Covid-19 RT-PCR testing and met the criteria for utilisation of the Covid-19 RT-PCR nasal swab test were included.

The AudibleHealth Dx SaMD device was used by both symptomatic and asymptomatic COVID-19 patients as well as healthy volunteers in the validation study.

After using the device, each participant was promptly swabbed for an RT-PCR test, said RAIsonance.

The AudibleHealth Dx uses artificial intelligence to analyse the sound of a person’s forced cough vocalisation in order to diagnose Covid-19.

The user interface is presented as a mobile application to enable quick and simple Covid-19 testing without the need for swabs, lines, trash, or expiration dates.

It enables the user to receive their test results on the app in around two minutes by coughing four to six times into their phone after downloading and registering the app.