evaluation of the audiblehealth dx ai/ml-based dx samd using fcv-sds in the diagnosis of covid-19 illness: clinical validation

Conditions: 2019 Novel Coronavirus Disease; 2019 Novel Coronavirus Infection; 2019-nCoV Disease; COVID-19 Pandemic; COVID-19 Virus Disease; COVID-19 Virus Infection; Coronavirus Disease 2019; Coronavirus Disease-19; SARS-CoV-2 Infection

Summary: the audiblehealth dx is a diagnostic software as a medical device (dx samd) consisting of an ensemble of software subroutines that interacts with a proprietary database of signal data signatures (sds), using artificial intelligence/machine learning (ai/ml) to analyze forced cough vocalization signal data signatures (fcv-sds) for diagnostic purposes. this study will evaluate the performance of the audiblehealth dx in comparison to a standard of care reverse transcriptase polymerase chain reaction (rt-pcr) test for the diagnosis of covid-19. a secondary purpose of the study will be usability testing of the device for participants and providers.

the study is a prospective, multi-site, non-inferiority trial comparing the audiblehealth dx to fda approved covid-19 rt-pcr testing to demonstrate non-inferiority of the ppa and npa when using this device to diagnose covid-19 illness. the audiblehealth dx test and the "biofire respiratory 2.1 (rp2.1)" (brand name) test will be performed for each participant during a single encounter. participants and staff will be blinded to audiblehealth dx results and the rt-pcr status at the time of testing. no one will know both results in real-time except for the site coordinators and unblinded statistician specifically authorized to have these results for enrollment, audit, data tracking, and data compiling purposes. • unblinding of the results will occur after the audiblehealth dx, rt-pcr, and the second rt-pcr results (if necessary for discordance) have been obtained. results for the rt-pcr test will be received by the participant according to the clinical site's protocol. target enrollment for this trial will be 65 covid-19 positive cases and 152 covid-19 negative cases, presuming a prevalence of 0.30 for a total of 217 subjects meeting all inclusion criteria.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * present for elective, outpatient covid-19 rt-pcr testing * meet the fda eua approved indications for use for rt-pcr nasal swab testing for covid-19 * stated willingness to comply with all trial procedures and availability for the duration of the trial * informed consent must be obtained prior to testing * ability to complete both the informed consent form and the screens on the medical device app in english (no translation to other languages is currently available) exclusion criteria: * any individual who was a part of the audiblehealth dx development, training, and usability trial (training and test data sets are to be kept strictly separate.) * less than 18 years of age * unable to produce a voluntary forced cough vocalization (fcv) * recent acute traumatic injury to the head, neck, throat, chest, abdomen or trunk * patent tracheostomy stoma * recent chest / abdomen / trunk trauma or surgery, recent / persistent neurovascular injury or recent intracranial surgery * medical history of cribriform plate injury or cribriform plate surgery, diaphragmatic hernia, external beam neck / throat / maxillofacial radiation, phrenic nerve injury/palsy, radical neck / throat / maxillofacial surgery, vocal cord trauma or nodules * since persons with aphasia may have difficulty in producing an fcv-sds in the time allotted by the app, this population also will be excluded from the current trial

Keywords: delta omicron fcv-sds artificial intelligence signal data signature forced cough vocalization dx samd samd diagnostic software as medical device software as medical device ai/ml