Evaluation of a Chest X-Ray AI Neural Network (RadGen SARS-CoV2 Detection System) for the Detection of RT-PCR Confirmed SARS-Cov2 Covid-19 Pneumonia
Overview
- Phase
- Not Applicable
- Sponsor
- Ensemble Group Holdings, LLC
- Enrollment
- 4,000
- Locations
- 1
- Primary Endpoint
- Diagnostic Performance of AI model
Overview
Brief Summary
This study investigates the diagnostic performance of an AI algorithm in the detection of COVID-19 pneumonia on chest radiographs.
Detailed Description
This is an international multi-center study. Chest radiographs (CXR) from different participating centers will be collected to develop an AI algorithm to detect COVID-19 pneumonia. This will be tested on external hold out datasets from different centers using SARS-CoV-2 by Real-Time Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Assay as ground truth.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All adult patients \>18 years of age
- •Attended any of the participating institutes between February 1, 2020 until September, 2020
- •Underwent both RT-PCR testing and frontal CXR (within 48 hours of PCR testing) for COVID-19 infection
- •frontal CXR of patients pre-covid pandemic
Exclusion Criteria
- •Unavailability of patient demographics and clinical data
- •Inconclusive RT-PCR results
- •CXR considered to be of non-diagnostic quality by the clinical radiology research team at each site
- •CXR not in a retrievable or processable format for AI inference
Outcomes
Primary Outcomes
Diagnostic Performance of AI model
Time Frame: 9 months
Performance (accuracy, sensitivity, specificity, false-positive rate (FPR), false-negative rate (FNR), and Area Under the Curve (AUC)) of the AI model in detection of COVID-19 pneumonia on their baseline CXR using RT-PCR and historical controls as gold standard in a multi-center / multi-national cohort.
Secondary Outcomes
No secondary outcomes reported