There’s an app for just about everything these days—including, now, to generate the results of an at-home COVID-19 test.
Just a few weeks after BD and Scanwell Health debuted their smartphone-based coronavirus diagnostic, Intrivo Diagnostics has begun rolling out its own rapid antigen test that connects to an artificial-intelligence-based app to guide users through the test-taking process, return their results and compile those findings into population-level databases.
Users begin by downloading the app through their iOS or Android app store or by scanning a QR code on the outside of the On/Go test kit’s box. The On/Go app will then guide them through the process of collecting a nasal swab, mixing it with the testing solution and applying the solution to a testing cartridge. Once completed, users snap a photo of the cartridge, and the app generates their results and any subsequent guidance within about 10 minutes.
The app saves the results of all On/Go tests taken by an individual, as well as their vaccine records, allowing it to be used as a secure digital COVID passport. If the tests are distributed by a school, workplace, venue or other organization, their results are compiled by On/Go’s AI platform to help track and mitigate outbreaks as they crop up.
Intrivo’s On/Go test received an emergency use authorization before BD’s Veritor diagnostic—FDA filings show the EUA for Intrivo’s offering arrived in early August, a few weeks before Veritor’s Aug. 24 authorization—but the company waited to unveil the test until it was ready for commercial launch.
The On/Go kit is now available for online purchase through the test’s dedicated website, Amazon and Walmart. Each kit includes two tests and retails for $34.99.
Additionally, millions of On/Go tests are slated to be distributed by the government to vulnerable populations at nursing homes, homeless shelters, military bases and more. The U.S. Department of Defense in September awarded Intrivo a $109.8 million contract to deliver 10 million test kits between this month and September 2022.
“Given the widespread COVID-19 testing shortages, it’s more important than ever that we’re providing a holistic testing-to-tracing solution that’s highly reliable, quick, affordable and easy to use,” said Reeve Benaron, Intrivo’s founder and co-CEO. “As a parent, businessman and huge sports fan, I understand how COVID-19 has disrupted all aspects of daily life. We’re excited to provide a trusted and accessible solution that will help contain this pandemic and help our loved ones and communities get back to living their lives to the fullest.”
A clinical validation study of the On/Go test kit found that, when compared to the results of an RT-PCR molecular test, it was able to detect 87% of positive samples and 98% of negative samples. It has been cleared for self-testing by patients ages 14 and older and for administration by an adult to children as young as 2 years old.
Intrivo, the exclusive distributor of COVID tests developed by Access Bio, already offers a host of other FDA-authorized tests, including RT-PCR and antibody diagnostics. The original version of its rapid antigen tests, then known as CareStart Antigen kits, were tapped by Amazon Business earlier this year to be sold to healthcare providers for point-of-care testing.