This article has been updated to clarify that Pelican's test is a rapid antigen diagnostic.
NEW YORK – Canary Global subsidiary Pelican Diagnostics said on Monday that it has received a CE mark for its rapid antigen Pelican COVID-19 Ultra-Rapid Mobile Test for the detection of SARS-CoV-2.
The testing kit consists of a handheld reusable digital reader and disposable testing cartridges that use nanosensor and direct detection technology to analyze the spike and nucleocapsid proteins in saliva to detect SARS-CoV-2, the company said. The diagnostic's limit of detection is 1 femtogram per milliliter, correlating with the current gold standard RT-PCR assays. Further, the test itself takes less than two minutes to return a result and has demonstrated 98 percent sensitivity and 100 percent specificity in detecting SARS-CoV-2, as well as its known variants, in both symptomatic and asymptomatic people, Canary added.
The device can also be wirelessly connected to a smartphone-based app for automated results reporting. A positive or negative reading appears on the screen when testing is complete, and the entire test report is available on the mobile app. Each disposable test cartridge contains multiple sensors and a unique QR code that's linked to the user's cell phone or another connected device.
The diagnostic, which is now cleared for sale in the European Union, is also being reviewed by the US Food and Drug Administration for Emergency Use Authorization as an over-the-counter, non-prescription self-test, the company said.
"The challenge with current rapid tests is that too often results are delivered after transmission already has begun. The more sensitive PCR tests take too long and are not suitable as point of care tests," Canary President and CEO Raj Reddy said in a statement. "The ability to detect SARS-CoV-2 early, before the onset of symptoms or those who never develop symptoms will help reduce household and community transmission, and enable fast clinical decisions for patient triage and care. The potential for its use to safely open businesses, schools and event venues is a game-changer."