First full at-home COVID-19 test

Axios – by Bryan Walsh

Gauss, a computer vision startup, and Cellex, a biotech company that works on diagnostics, are announcing the first rapid COVID-19 test that can be fully performed by people at home without involving a laboratory.

Why it matters: Experts agree that the U.S. still needs far more widespread testing to help contain the coronavirus pandemic. An antigen test that could be performed and provide results rapidly at home could help reduce testing delays and allow people to quickly find out whether they need to isolate because of a COVID-19 infection.

How it works: In the antigen test, which was developed by Cellex, a user will take a nasal swab to both nostrils, and then place the swab in a small vial filled with a buffer solution.

• Four droplets from the tube are placed on a rapid test cassette, and test lines will show up of varying intensity, based on whether and how much virus is in the sample.
• Users will then take a picture of the rapid test, and Gauss’s app will use AI to deliver back the results — all within 15 minutes.

Of note: While other rapid diagnostics have been developed that allow users to test themselves at home, those earlier methods still required people to send in samples to a lab or health facility for processing.

• The Gauss/Cellex diagnostic would be the first test that can be done to completion at home.
• Cellex CEO James Li says the test demonstrates nearly 90% sensitivity — how often a test generates a correct positive result — compared to PCR tests, and nearly 100% specificity, or how often it produces a correct negative result.

What is important for COVID-19 pandemic management is that this is a tool that will allow people to self-monitor and self-isolate.

— James LiWhat to watch: Whether the FDA gives the new test an Emergency Use Authorization, which would allow it to more rapidly come to market.

• There’s also the question of price, although Li says that “our goal is to make this assay as widely available as possible.”

The bottom line: Quick and easy at-home tests would certainly help reduce the spread of COVID-19, and they show how the pandemic has accelerated the coming of distributed medicine.

Axios