Computer vision company Gauss teamed up with biotechnology company Cellex to develop a rapid, at-home and point-of-care COVID-19 antigen test.
While there are other at-home COVID-19 diagnostic tests available, at least two companies are working on rapid antigen tests that can be performed by people at home without involving a laboratory.
The Gauss and Cellex test has not yet gained Food and Drug Administration (FDA) approval. The companies are pushing for FDA Emergency Use Authorization (EUA) some time this fall.
Sona Nanotech, based in Halifax, Canada, is awaiting FDA approval for its rapid detection COVID-19 antigen test. The test utilizes a nasopharyngeal swab and provides a result in 15 minutes without the use of either laboratory equipment or a reader, according to the company.
There is a growing consensus among public health officials and business leaders that a widely-accessible rapid antigen testing solution is needed to decrease the public health threat from COVID-19 and mitigate the pandemic’s economic impact until a vaccine is widely available.
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An antigen test that can be taken at home and provides rapid results could help reduce testing delays and allow people to quickly find out whether they need to isolate because of a COVID-19 infection, the companies said.
Cellex was the first company to receive an FDA Emergency Use Authorization for rapid COVID-19 antibody testing in April and is now in advanced clinical trials with a rapid antigen test that targets the nucleocapsid (N) protein on the SARS-CoV-2 virus.
When paired with a mobile app from Gauss that enables non-expert users to perform and interpret the test with an iPhone or Android phone, its use can be expanded to aid in the rapid diagnosis of SARS-CoV-2 infections in both at-home and point-of-care settings, the company said.
To perform at-home testing, users collect a nasal swab sample and perform the rapid antigen test. Within 15 minutes, the app prompts the user to scan their rapid test with their smartphone and then processes the image with an end-to-end neural network architecture optimized for the Cellex assay.
The app informs the user if the test result is negative or positive for SARS-CoV-2 antigens within seconds, according to the companies.
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Gauss’s patent-pending, AI-driven assay reading technology overcomes the limit of detection of the untrained human eye and can also minimize inter-reader variability routinely seen in interpreting antigen test results.
"This AI-enabled COVID-19 antigen test for home use will make self-monitoring and isolation feasible, thereby playing a significant role in changing the trajectory of the COVID-19 pandemic in America and beyond," said James Li, Cellex founder and CEO in a statement.
The Gauss mobile app also can facilitate automatic reporting of data to health authorities and give users a mobile pass temporarily storing their status. For point-of-care and laboratory users, the app can enable clinical users to automatically send data to electronic medical record (EMR) and laboratory information systems as well, according to the company.